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EC number: 247-956-7 | CAS number: 26748-47-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
For 1-Methyl-1-phenylethyl peroxyneodecanoate (target substance), suitable data are available to assess the acute toxicity. In an acute oral in vivo toxicity study conducted similar to OECD 401, Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (target substance, 90.2% purity). In this study, the oral LD50 in rats in considered to be 5126 mg/kg bw. In a second available acute oral in vivo toxicity study conducted according to OECD 401, Sprague-Dawley rats were given a single oral dose of TRIGONOX 99-C75 (target substance, 75% purity). In this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.
In an acute inhalation toxicity study similar to OECD 403, Charles River CD rats were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl-) for 1 hour via whole body exposure at a concentration of 20.4 mg/L. No mortality occurred during the 14-day observation period.
In an acute dermal toxicity study conducted similar to OECD 402, groups of New Zealand White rabbits (three/sex) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) for 72 hours at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Based on the results, the dermal LD50 was considered to be within < 19800 and > 7940 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977-09-02 to 1978-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid - Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Weight at study initiation: 200 - 248 g
- Housing: Animals were housed by sex in groups of 5 rats per cage in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Laboratory Chow (withheld during overnight period preceding oral administration)
- Temperature and humidity controlled quarters - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- once (to male and female): 2034, 3229, 5126, 8137, 12918 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
OBSERVATIONS
- Weighing: Initially, at 7 and 14 days
- Mortality/Viability: During first four hours after dosing, at 24 hours and daily thereafter - Statistics:
- Statistical Reference
LD50 values and associated 95% confidence interval, slope of dose mortalitiy curve
References:
- Weil, C.S. 1952. Tables for Convenient Calculation of Median Effective Dose and Instruction in Their Use. Biometrics, 8: 249 - 263
- Thompson, W.R. and Weil, C.S. 1952. On the Construction of Tables for Moving Average Interpolation. Biometrics, 8: 51 - 54
- Eby, R. 1957. Statistical Tables for Dose Evaluation, Report No. 5711. Miles - Ames Research Laboratoy, Elkhart, Indiana - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 4 068 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 132 - <= 5 284
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6 458 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 5 590 - <= 7 462
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 126 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 4 294 - <= 6 118
- Mortality:
- At 8137 and 12918 mg/kg all animals died. At 5126 mg/kg 4/5 female animals were found dead and at 3229 mg/kg 1/5 female animals died. No deaths occured at a dose of 2034 mg/kg.
For individual results see Table 1 in box 'Any other information on results incl. tables'. - Clinical signs:
- No data
- Body weight:
- A trend in decreasing body weight gain is observed in survived animals.
For individual results see Table 1 in box 'Any other information on results incl. tables'. - Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The presented studies finds that 1-Methyl-1-phenylethyl peroxyneodecanoate is not of acute oral toxicity and that GHS criteria are not met.
- Executive summary:
In a primary acute oral toxicity study (similar to OECD 401), Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (1-Methyl-1-phenylethyl peroxyneodecanoate, 90.2% purity), suspended in corn oil. Animals then were observed for 14 days. Due to mortality distribution, the oral LD50 in rats in considered to be 6458 mg/kg bw for males, 4068 mg/kg bw for females and 5126 mg/kg bw for both sexes.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-10-9 to 1992-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- TEST MATERIAL
- Brand name: TRIGONOX 99-C75
- Batch No. 0509207222002
- CAS No.: 26748-47-0
- Purity: 75% Cumylperoxyneodecanoate in aromatic free mineral spirit (CAS No.: 26748-47-0 and 31807-55-3)
- Appearance: clear colorless liquid
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Akzo Chemicals International BV, Barcham Wuytierslaan 10, P.O. Box 975, 3800 AZ Amersfoort, The Netherlands; batch-no.: 0509207222002
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: freezer
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was prepared at the appropriate concentration in maize oil. - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.K.) Limited, Margate, Kent, England
- Age at start of treatment: approx. 5 weeks
- Body weight at start of treatment: males 137 - 149 g, females 128 - 142 g
- Fasting period before study: Food was removed from the hoppers at approx. 15 hours on the day before dosing.
- Identification: tail tattoos
- Acclimatization: at least 5 days
- Housing: Animals were housed in stainless steel grid cages (Stephen Clark Fabrications Limited, Alva, Clackmannanshire, Scotland). The grid floor ensured rapid removal of waste material to undertray. Five animals of the same sex were accommodated in each cage.
- Diet: ad libitum, pelleted rodent diet (RM-1 S.Q.C., from Special Diets Services Limited, Witham, Essex, England); removal of food for approx. 21 hours before administration of test material until 3 hours after administration
- Water: ad libitum, tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Humidity (%): 36 - 55 % R.H.
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes per hour: 15 (without re-circulation) - Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Clinical signs: Day 1: 1 h, 3 h and 5 h post-exposure; daily thereafter; Weighing: day before dosing and Day 1, 8 and 15
- Necropsy of survivors performed: Yes, all animals were sacrificed
- Other examinations performed: no- Statistics:
- LD50 values and associated 95% confidence interval
- Preliminary study:
- Group of one male and one female rat given single oral administration of TRIGONOX 99-C75 at single dosage of 800 mg/kg bw, at constant volume-dosage of 10 mL/kg in maize oil. No deaths occured.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured. See also Table 1 in box 'Any other information on results incl. tables'.
- Clinical signs:
- Clinical signs as underactivity, staggering gait, piloerection and hunched posture on the day of dosing were observed. The animals were overtly normal by the following day.
For individual results, see Table 2 in box 'Any other information on results incl. tables'. - Body weight:
- All animals achieved expected body weight gains.
See Table 4 in box 'Any other information on results incl. tables'. - Gross pathology:
- Necropsy on day 15 revealed no significant macroscopic lesion.
See Table 5 in box 'Any other information on results incl. tables'. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dosage (LD50) of the test material was greater than 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study conducted according to OECD guideline 401, fasted Sprague-Dawley rats (5/sex/dose) were given a single oral dose of TRIGONOX 99-C75 (1-Methyl-1-phenylethyl peroxyneodecanoate, 75% purity), suspended in maize oil, at a dose of 2000 mg/kg bw and were observed for 15 days. Due to the absence of mortality and low adverse clinical signs, the oral LD50 in rats is considered to be greater than 2000 mg/kg.
Referenceopen allclose all
Table 1: Mortality and LD50 Values
Exposure Conc. mg/kg |
Number of Deaths |
Total Mortalities |
|||||||||||||||||
|
Postexposure |
||||||||||||||||||
Hrs. |
Days |
||||||||||||||||||
0 - 4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 - 14 |
||||||||||||
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
Male |
Female |
Total |
|
2034 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0/5 |
0/5 |
0/10 |
3229 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
0/5 |
1/5 |
1/10 |
5126 |
|
|
|
2 |
|
2 |
|
|
|
|
|
|
|
|
|
|
0/5 |
4/5 |
4/10 |
8137 |
1 |
3 |
3 |
2 |
|
|
1 |
|
|
|
|
|
|
|
|
|
5/5 |
5/5 |
10/10 |
12918 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5/5 |
5/5 |
10/10 |
The Acute Oral LD50 Values and 95% Confidence Limits
Male Rats: 6458 (5590 - 7462)
Female Rats: 4068 (3132 - 5284)
Combined Male and Female Rats: 5126 (4294 - 6118)
Slope
Male Rats: 1.66
Female Rats: 1.66
Combined Male and Female Rats: 1.66
Table 2: Body Weights obtained during 14 -day observation period
Dosage Level mg/kg |
Individual Rat No. |
Sex |
Control Weight (grams) |
7-Day Weight (grams) |
14-Day Weight (grams) |
2034 |
70485 |
Male |
211 |
295 |
334 |
70486 |
Male |
231 |
272 |
286 |
|
70487 |
Male |
244 |
312 |
343 |
|
70488 |
Male |
248 |
296 |
323 |
|
70498 |
Male |
243 |
291 |
324 |
|
70490 |
Female |
214 |
248 |
256 |
|
70491 |
Female |
210 |
243 |
258 |
|
70492 |
Female |
208 |
242 |
273 |
|
70493 |
Female |
202 |
247 |
254 |
|
70494 |
Female |
200 |
224 |
243 |
|
3229 |
70354 |
Male |
200 |
258 |
310 |
70355 |
Male |
221 |
245 |
292 |
|
70356 |
Male |
215 |
281 |
312 |
|
70357 |
Male |
201 |
264 |
324 |
|
70358 |
Male |
213 |
280 |
325 |
|
70349 |
Female |
212 |
234 |
226 |
|
70350 |
Female |
200 |
240 |
246 |
|
70351 |
Female |
214 |
238 |
260 |
|
70352 |
Female |
200 |
Died |
Died |
|
70353 |
Female |
216 |
252 |
241 |
|
5126 |
70364 |
Male |
200 |
211 |
222 |
70365 |
Male |
201 |
244 |
308 |
|
70366 |
Male |
205 |
269 |
318 |
|
70367 |
Male |
202 |
225 |
258 |
|
70368 |
Male |
207 |
248 |
288 |
|
70359 |
Female |
200 |
235 |
216 |
|
70360 |
Female |
200 |
Died |
Died |
|
70361 |
Female |
201 |
Died |
Died |
|
70362 |
Female |
220 |
Died |
Died |
|
70363 |
Female |
210 |
Died |
Died |
|
8137 |
70374 |
Male |
201 |
Died |
Died |
70375 |
Male |
203 |
Died |
Died |
|
70376 |
Male |
208 |
Died |
Died |
|
70377 |
Male |
205 |
Died |
Died |
|
70378 |
Male |
200 |
Died |
Died |
|
70369 |
Female |
210 |
Died |
Died |
|
70370 |
Female |
218 |
Died |
Died |
|
70371 |
Female |
220 |
Died |
Died |
|
70372 |
Female |
206 |
Died |
Died |
|
70373 |
Female |
204 |
Died |
Died |
|
12918 |
70384 |
Male |
215 |
Died |
Died |
70385 |
Male |
200 |
Died |
Died |
|
70386 |
Male |
210 |
Died |
Died |
|
70387 |
Male |
200 |
Died |
Died |
|
70388 |
Male |
200 |
Died |
Died |
|
70379 |
Female |
204 |
Died |
Died |
|
70380 |
Female |
200 |
Died |
Died |
|
70381 |
Female |
210 |
Died |
Died |
|
70382 |
Female |
210 |
Died |
Died |
|
70383 |
Female |
202 |
Died |
Died |
Table 1: Mortality
Dosage (mg/kg bw) |
Male |
Female |
Combined |
2000 |
0/5 |
0/5 |
0/5 |
Table 2: Distribution of signs - MALE
Signs of reaction to treatment |
Cage, sex and animal number X651 MALE |
Number showing effect at time after dosing |
|||||||||||||||||||||||||||||||||||
Hour |
Day |
||||||||||||||||||||||||||||||||||||
801 |
802 |
803 |
804 |
805 |
1/4 |
1/2 |
1 |
3 |
5 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||||||||
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
|||||||||||
Decedents: None |
|||||||||||||||||||||||||||||||||||||
Animals survivingat Day 15 |
|||||||||||||||||||||||||||||||||||||
No abnormality detected |
|
|
|
|
|
5 |
5 |
|
|
|
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Underactivity |
+ |
+ |
+ |
+ |
+ |
|
|
|
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Staggering gait |
+ |
+ |
+ |
+ |
+ |
|
|
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Piloerection |
+ |
+ |
+ |
+ |
+ |
|
|
|
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
+ |
+ |
+ |
+ |
+ |
|
|
|
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number of survivors: 5 |
+ Indicates an animal exhibiting a sign: a = am; p = pm
Table 3: Distribuion of signs FEMALE
Signs of reaction to treatment |
Cage, sex and animal number X651 MALE |
Number showing effect at time after dosing |
|||||||||||||||||||||||||||||||||||
Hour |
Day |
||||||||||||||||||||||||||||||||||||
806 |
807 |
808 |
809 |
810 |
1/4 |
1/2 |
1 |
3 |
5 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||||||||
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
p |
a |
|||||||||||
Decedents: None |
|||||||||||||||||||||||||||||||||||||
Animals survivingat Day 15 |
|||||||||||||||||||||||||||||||||||||
No abnormality detected |
|
|
|
|
|
5 |
5 |
|
|
|
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Underactivity |
+ |
+ |
+ |
+ |
+ |
|
|
2 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Staggering gait |
+ |
+ |
+ |
+ |
+ |
|
|
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Piloerection |
+ |
+ |
+ |
+ |
+ |
|
|
|
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hunched posture |
+ |
+ |
+ |
+ |
+ |
|
|
1 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total number of survivors: 5 |
Table 4: Individual body weights
Bodyweight (g) |
Animal number and sex |
||||||
801M |
802M |
803M |
804M |
805M |
|||
Day |
-1 |
149 |
137 |
139 |
147 |
141 |
|
Day |
1 |
133 |
123 |
122 |
123 |
121 |
|
Day |
8 |
214 |
192 |
199 |
203 |
189 |
|
Day |
15 |
280 |
256 |
268 |
259 |
255 |
|
Increment |
131 |
119 |
129 |
112 |
114 |
||
Mean of Increment |
|
|
|
|
121 |
||
|
806F |
807F |
808F |
809F |
810F |
||
Day |
-1 |
128 |
137 |
142 |
138 |
130 |
|
Day |
1 |
116 |
119 |
127 |
121 |
117 |
|
Day |
8 |
168 |
178 |
193 |
178 |
164 |
|
Day |
15 |
196 |
207 |
223 |
196 |
184 |
|
Increment |
68 |
70 |
81 |
58 |
54 |
||
Mean of increment |
|
|
|
|
66 |
Table 5: Necropsy observation
Aminal number and sex |
Died or Sacrificed |
Time of death Day |
Necropsy observation |
801M |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
802M |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
803M |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
804M |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
805M |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
806F |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
807F |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
808F |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
809F |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
810F |
Sacrificed |
15 |
External: No significant lesion Internal: No significant lesion |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Guideline study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-04-04 to 1978-07-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 1 hour exposure instead of 4 hours
- GLP compliance:
- not specified
- Test type:
- traditional method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test material: SN-1-4462-71X
- Chemical name: cumyl peroxyneodecanoate
- Purity: 75.5% (0.19% Hydro, 896 ppm Cl)
- Appearance: pale yellow liquid - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS & ENVIRONMENTAL CONDITIONS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: no data
- Weight at study initiation: 235-242 g (male rats), 200-214 g (female rats)
- Fasting period before study: no data
- Housing: The rats were housed individually in wire-mesh cages and were kept throughout the pre- and post-exposure periods in a temperature and humidity controlled room in accordance with standards outlined in the "Guide For the Care and Use of Laboratory Animals; DHEW No. (N.I.H. 74-23) 1974". During exposure, the rats were caged individually in compartmented wire-mesh exposure cages. The cages were placed in a 160-liter cubical, stainless steel and glass chamber. A constant chamber airflow was maintained by means of a rotary centrifugal air pump located at the exhaust side of the chamber. The chamber exhaust was filtered with an activated charcoal filter and a Cambridge Absolute® filter before being discharged outside of the laboratory.
- Diet (e.g. ad libitum): Purina Laboratory chow, ad libitum (except in the exposure chamber)
- Water (e.g. ad libitum): ad libitum (except in the exposure chamber)
- Acclimation period: 1 week - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- The vapors of the compound were generated by metering the liquid at the rate of 0.494 mL/min with a Harvard Infusion pump into a positive pressure atomizer located near the chamber air inlet at the top of the exposure chamber. An air pressure of 10 psig, with an air-flow rate of 8 L/min, was applied to the atomizer which aerosolized the liquid for rapid vaporization. The vapors and aerosols emerging from the atomizer were diluted by the incoming chamber air at the rate of 14 L/min to the desired concentration. The "metered" concentration of the compound (20.4 mg/L) in the chamber atmosphere was calculated from the ratio of the rate of liquid dissemination (449.5 mg/min*) to the rate of total chamber airflow (22 L/min). The total chamber airflow represents the volume of air ejected from the atomizer plus the volume of make-up air passing through the chamber per unit time.
*The specific gravity of the liquid was gravimetrically determined to be 0.91 - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 1 h
- Concentrations:
- 20.4 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for toxic signs and mortility were made during and immediately following the 1 hour exposure period and twice daily thereafter for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to the 1 hour exposure and periodically thereafter.
- Necropsy of survivors performed: yes - Statistics:
- no data
- Preliminary study:
- n.a.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 20.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- None of the rats died in the experiment.
- Clinical signs:
- other: The immediate response of the rats to the experimental atmosphere was an increase of activity in preening. After several minutes of exposure, this activity decreased. After 20 minutes of exposure 50% of the rats exhibited slight dyspnea. At 30 minutes, al
- Body weight:
- A slight body weight loss was observed in the rats for 1-5 day post-exposure. By the end of the 14-day post-exposure, the body weights of all the rats exceeded those of the pre-exposure values. See Table 1 in box 'Any other information on results incl. tables'.
- Gross pathology:
- Gross pathological examination of the rats which were sacrificed at the end of the experimental period revealed gray patches on the lungs of 1 male rat and no compound related pathologic changes in the remaining 9 rats.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute inhalation study, Charles River CD rats were inhaled via whole-body exposure to 20.4 mg/L for 1 hour. No mortality occurred during the 14-day observation period. Based on the results, the LC50 is considered to be greater than 20.4 mg/L.
- Executive summary:
In an acute inhalation toxicity study conducted similar to OECD 403, groups of Charles River CD rats (5/sex) were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl-) for 1 hour to whole body at a concentration of 20.4 mg/L. Animals then were observed for 14 days. No mortality occurred. During exposure, animals showed an increase of activity in preen in and all rats exhibited slight dyspnea and some rats exhibited salivation. One rat exhibited eye squint on day 1 post-exposure. A slight body weight loss was observed in the rats for day 1 to 5 post-exposure. In one male rat, grey patches on the lungs were observed. Based on the results, the LC50 is greater than 20.4 mg/L.
Reference
Table 1: Individual Body Weights
Individual body weights (in grams) | |||||||
Pre-exposure | Post-exposure (Days) | ||||||
0 | 1 | 3 | 5 | 7 | 14 | ||
Rat no. | Sex | ||||||
1 | M | 235 | 220 | 232 | 262 | 286 | 346 |
2 | M | 240 | 225 | 240 | 260 | 285 | 328 |
3 | M | 238 | 224 | 236 | 258 | 276 | 320 |
4 | M | 235 | 221 | 238 | 258 | 271 | 300 |
5 | M | 242 | 224 | 236 | 255 | 272 | 295 |
6 | F | 200 | 192 | 200 | 211 | 218 | 236 |
7 | F | 200 | 202 | 205 | 212 | 226 | 228 |
8 | F | 210 | 192 | 222 | 211 | 224 | 240 |
9 | F | 214 | 200 | 210 | 220 | 229 | 250 |
10 | F | 210 | 199 | 200 | 207 | 224 | 232 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Comparable to guideline study
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977-09-02 to 1978-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 2 animals per dose group were used
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2%
- Appearance: viscous yellowish liquid
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Pennwalt Corporation (Lucidol Division), Buffalo, New York - Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sweetwater Farm, Hillsboro, Ohio
- Weight: 2343 - 3000 g
- Housing: Animals were housed individually in hanging wire-mesh cages
- Water: ad libitum
- Diet: ad libitum; Purina Rabbit Chow
- Temperature and humidity controlled quarters - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- The hair was removed from the back of each rabbit (20 – 30% of the body surface) with an electric clipper. The test material
- Duration of exposure:
- 24 h
- Doses:
- 500, 1250, 3150, 7940 and 19800 mg/kg bw
- No. of animals per sex per dose:
- 1 male and 1 female rabbits
- Control animals:
- no
- Details on study design:
- TEST SITE
- Area of exposure: Back; on 20-30% of the body surface the hair was removed.
- % coverage:
- Type of wrap if used: The area of application was wrapped with gauze bandaging and occluded with Saran Wrap.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with tepid tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Dose volume: 500, 1250, 3150, 7940 and 19800 mg/kg - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 940 - < 19 800 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The two rabbits at the 19800 mg/kg dosage level died. None of the other rabbits died during the 14-day observation period.
- Clinical signs:
- No data
- Body weight:
- Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.
For individual results see Table 1 in box 'Any other information on results incl. tables'. - Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the acute dermal LD50 of 1-methyl-1-phenylethyl peroxyneodecanoate (90.2% purity) was found to be greater than 7940 mg/kg but less than 19800 mg/kg.
- Executive summary:
In an acute dermal toxicity study (similar to OECD 402), groups of New Zealand White rabbits (1/sex/dose) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) in for 24 hours to 20 – 30% of the body surface at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Animals then were observed for 14 days. Under the conditions of this study, the acute dermal LD50 of 1 -Methyl-1-phenylethyl peroxyneodecanoate was found to be greater than 7940 mg/kg but less than 19800 mg/kg.
Body weight gain was noted for all surviving animals during the test period, except for one male at 500 mg/kg and one female at 7940 mg/kg bw.
No changes in body weight gain was observed. Mortality occurred at the highest dose level (19800 mg/kg bw) in both animals. None of the other rabbits died during the 14-day observation period.
Reference
Table 1: Body Weights: The following body weights were obtained during the 14-day observation period
Dosage level mg/kg |
Individual rabbit no. |
Sex |
Control Weight (grams) |
7-Day weight (grams) |
14-day weight (grams) |
500 |
30237 |
Male |
2575 |
2693 |
2508 |
30238 |
Female |
2720 |
2844 |
2978 |
|
1250 |
30331 |
Male |
2955 |
3038 |
3215 |
30254 |
Female |
3000 |
3226 |
3465 |
|
3150 |
30259 |
Male |
2841 |
2835 |
3081 |
30340 |
Female |
2786 |
2665 |
2946 |
|
7940 |
30339 |
Male |
2770 |
2668 |
2874 |
30338 |
Female |
2446 |
2251 |
2326 |
|
19800 |
30327 |
Male |
2669 |
Died |
Died |
30336 |
Female |
2343 |
Died |
Died |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 7 940 mg/kg bw
- Quality of whole database:
- Comparable to guideline study
Additional information
For 1-Methyl-1-phenylethyl peroxyneodecanoate (target substance), suitable data are available to assess the acute toxicity. In an acute oral in vivo toxicity study conducted similar to OECD 401, Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (target substance, 90.2% purity). In this study, the oral LD50 in rats in considered to be 5126 mg/kg bw. In a second available acute oral in vivo toxicity study conducted according to OECD 401, Sprague-Dawley rats were given a single oral dose of TRIGONOX 99-C75 (target substance, 75% purity). In this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.
In an acute inhalation toxicity study similar to OECD 403, Charles River CD rats were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl-) for 1 hour via whole body exposure at a concentration of 20.4 mg/L. No mortality occurred during the 14-day observation period.
In an acute dermal toxicity study conducted similar to OECD 402, groups of New Zealand White rabbits (three/sex) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) for 72 hours at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Based on the results, the dermal LD50 was considered to be within < 19800 and > 7940 mg/kg bw.
Justification for classification or non-classification
Based on the available data the target substance 1-metyl-1-phenylethyl peroxyneodecanoate does not warrant classification for acute toxicity. LD50 values for the dermal and oral route were above the limit values of the relevant OECD guidelines. In an acute inhalation study no mortality occurred and the LC50 is considered to be greater than 20.4 mg/L.
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