Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-618-5 | CAS number: 85-60-9
- 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
Acute oral LD50 > 2000 mg/kg bw.
Acute dermal LD50 > 2000 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 14 January 1997 to 06 March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD & EU test guidelines in compliance with GLP and reported with a valid GLP certificate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley CD (Crl:CD BR) strain rats supplied by Charles River (UK) Ltd., Margate, Kent, UK. were used. At the start of the main study the males weighed 230 to 251g, and the females 203 to 2298, and were eight to twelve weeks of age. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 20 to 21 °C and relative humidity of 46 to 55%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Range finding study: 1 male & 1 female
Main study: 5 males & 5 females - Control animals:
- no
- Details on study design:
- Range-finding Study: A range-finding study was performed to establish a dosing regime as follows: IN TABLE FORM ATTACHED UNDER Any other information.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for five days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed
Main Study: Based on the results of the range-finding study a further group of animals was treated as follows: IN TABLE FORM - ATTACHED UNDER Any other information.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made. - Preliminary study:
- Range-finding Study: There were no deaths or clinical signs of toxicity.
Based on this information, a dose level of 2000 mg/l- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
TABLE 2: INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY
Dose Level mg/kg
Animal Number and Sex
Effects Noted After Dosing (Hours)
Effects Noted During Period After Dosing (Days)
½
1
2
4
1
2
3
4
5
6
7
8
9
10
11
12
13
14
2000
3-0 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3-1 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3-2 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3-3 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3-4 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4-0 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4-1 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4-2 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4-3 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4-4 Male
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0 = no signs of systemic toxicity
TABLE 3: INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT CHANGES IN THE MAIN STUDY
Dose Level mg/kg
Animal Number and Sex
Bodyweight (g) at Day
Bodyweight Gain (g) During Week
0
7
14
1
2
2000
3-0 Male
230
301
348
71
47
3-1 Male
251
300
3378
49
37
3-2 Male
239
304
351
65
47
3-3 Male
232
308
374
76
66
3-4 Male
233
306
362
73
56
4-0 Female
219
242
269
23
27
4-1 Female
211
240
266
29
26
4-2 Female
205
228
242
23
14
4-3 Female
203
232
250
29
18
4-4 Female
229
250
269
21
19
TABLE 4: INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY
Dose Level mg/kg
Animal Number and Sex
Time of Death
Macroscopic Observations
2000
3-0 Male
Killed Day 14
No abnormalities detected
3-1 Male
Killed Day 14
No abnormalities detected
3-2 Male
Killed Day 14
No abnormalities detected
3-3 Male
Killed Day 14
No abnormalities detected
3-4 Male
Killed Day 14
No abnormalities detected
4-0 Female
Killed Day 14
No abnormalities detected
4-1 Female
Killed Day 14
No abnormalities detected
4-2 Female
Killed Day 14
No abnormalities detected
4-3 Female
Killed Day 14
No abnormalities detected
4-4 Female
Killed Day 14
No abnormalities detected
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material, NAUGALUBE 531, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.
- Executive summary:
Astudy was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of CouncilDirective 67/548/EEC). The study was performed in compliance with the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 11 to 25 March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD & EU test guidelines in compliance with GLP and reported with a valid GLP certificate.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Sprague-Dawley CD (Crl : CD BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent were used. At the start of the study the males weighed 208 to 229g, and the females 21 6 to 239g, and were approximately eight to twelve weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
The animals were housed in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 to 22 °C and relative humidity of 47 to 53%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness. - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers.
The calculated volume of the test material, as received, was applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The bandage was further secured with a piece of BLEN DERM wrapped around each end. The animals were caged individually for the 24-hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the remainder of the study period. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females used
- Control animals:
- not required
- Details on study design:
- The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J H (1 977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC
Any other skin reactions, if present were also recorded.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the animal's exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No signs of skin irritation were noted during the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material, NAUGALUBE 531, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.
- Executive summary:
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The study was performed in accordance with the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
A group of ten animals (five males and five females) was given a single 24-hour, semi occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study. No signs of skin irritation were noted during the study.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.
Reference
TABLE 1: INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period after Dosing (Days) |
||||||||||||||||
½ |
1 |
2 |
3 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity
TABLE 2: INDIVIDUAL DERMAL REACTIONS
Dose Level mg/kg |
Animal Number and Sex |
Observation |
Effects Noted After Initiation of Exposure (Days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
1-0 Male |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
1-1 Male |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
1-2 Male |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
1-3 Male |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
1-4 Male |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-0 Female |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-1 Female |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-2 Female |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-3 Female |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
|
2-4 Female |
Erythema Oedema Other |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 = no signs of dermal irritation
TABLE 3: INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT CHANGES
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
229 |
275 |
328 |
46 |
53 |
1-1 Male |
215 |
238 |
259 |
23 |
21 |
|
1-2 Male |
208 |
254 |
296 |
46 |
42 |
|
1-3 Male |
218 |
261 |
305 |
43 |
44 |
|
1-4 Male |
222 |
271 |
319 |
49 |
48 |
|
2-0 Female |
222 |
233 |
245 |
11 |
12 |
|
2-1 Female |
219 |
231 |
243 |
12 |
12 |
|
2-2 Female |
216 |
236 |
241 |
20 |
5 |
|
2-3 Female |
239 |
256 |
271 |
17 |
15 |
|
2-4 Female |
223 |
223 |
235 |
2 |
10 |
TABLE 4: INDIVIDUAL NECROPSY FINDINGS
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Male |
Killed Day 14 |
No abnormalities detected |
1-1 Male |
Killed Day 14 |
No abnormalities detected |
|
1-2 Male |
Killed Day 14 |
No abnormalities detected |
|
1-3 Male |
Killed Day 14 |
No abnormalities detected |
|
1-4 Male |
Killed Day 14 |
No abnormalities detected |
|
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Killed Day 14 |
No abnormalities detected |
|
2-4 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The supporting studies for the acute oral and dermal results supports the findings in the key studies - not classified.
The read across to the structural analogue has been identified as the key study as the data is better quality (Klimisch 1) compared to the supporting studies (Klimisch 4) performed on the actual substance being registered.
Justification for selection of acute toxicity – oral endpoint
Study performed to OECD & EU test guidelines. Substance is a read across to a structural analogue.
Justification for selection of acute toxicity – dermal endpoint
Study performed to OECD & EU test guidelines. Substance is a read across to a structural analogue.
Justification for classification or non-classification
Based on the data available the substance does not trigger any of the requirements for classification. The registered substance is therefore not classified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.