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EC number: 448-300-4 | CAS number: 88642-03-9
- 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
Based on the results of an OECD 420 compliant study, the oral LD50 of the test item was found to be greater than 2000 mg/kg bw/d.
Based on the results of an OECD 402 compliant study, the dermal LD50 of the test item was found to be greater than 2000 mg/kg bw/d.
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:
- key study
- Study period:
- 2003-10-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 138 - 166 g
- Fasting period before study: overnight prior to dosing
- Housing: The rats were kept in transparent polycarbonate cages (macrolone type III, floor area 810 cm2) with two or three in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3 °C
- Humidity: 55 +/- 15 %
- Air changes: 10 per hr
- Photoperiod: 12 / 12 hrs dark / hrs light
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 4 females (main study)
1 female (pre-test) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Preliminary study:
- The animal included in the sighting study (animal No. 1) survived the treatment and showed slight signs of toxicosis. The rat had a normal body weight gain during the study period. It showed piloerection 30 min. after the application of the test item. After 2 and 4 hours a hunched posture and piloerection were observed, whereas the rat still showed only piloerection after 6 hours. From day 1 until the end of the observation period on day 14 the animal was free of any abnormalities. The post mortem inspection revealed no pathological abnormalities.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the female rats died on account of the treatment nor did they show marked signs of toxicosis.
- Clinical signs:
- other: Animals No. 2, No. 3, No. 4 and No. 5 showed a hunched posture and piloerection 30 min., 2 and 4 hours after the application of the test item. At animal No. 2 a tremor was additionally recorded after 4 hours. After 6 hours all four animals were marked wit
- Gross pathology:
- The gross necropsy of the animals revealed no pathological abnormalities.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the LD50 of the test item was found to be greater than 2000 mg/kg bw/d.
- Executive summary:
The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001. The study was initiated with a sighting study, in which one female rat was given the test item in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Based on the results from the sighting study the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment and showed signs of toxicosis ranging from slight to moderate.
Reference
Table 1 Body weight group mean values [g] – Main study
Dose mg/kg bw |
sex |
Day 0 |
Day 7 |
Day 14 |
||||||
2000 |
female |
mean |
SD |
n |
mean |
SD |
n |
mean |
SD |
n |
143 |
5 |
4 |
178 |
8 |
4 |
200 |
5 |
4 |
Table 2 Daily Observations – Main study
Animal No |
Dose mg/kg bw |
sex |
min |
hours after dosing |
Day after dosing |
|||||||||
30 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
|||
2 |
2000 |
Female |
BE |
BE |
BEK |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
3 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
4 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
5 |
2000 |
Female |
BE |
BE |
BE |
BEK |
BE |
A |
A |
A |
A |
A |
A |
A |
Key to table 2
A Normal behaviour
B Piloerection
C Salivation
D Apathy
E Hunched posture/ abdominal rigidity
F Body weight loss or emaciation
G Vomitting
H Diarrhoea
I Constipation
J Compulsive behaviour/ Pruritus
K Tremor
L Paresis
M Discharge, abnormal
N Anaemia
O Blood around nose and eyes
P Dehydration
Q Dyspnea
R Cyanosis
S Ataxia
T Paralysis
U Comatose
V Moribund
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline study.
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-07-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: Males 52 days; females 63 days
- Weight at study initiation: Males 228 - 253 g; females 200 - 219 g
- Fasting period before study: not specified
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: 55 +/- 15 %
- Photoperiod: 12 hrs dark / hrs light
- Type of coverage:
- semiocclusive
- Vehicle:
- other: sesame oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: animal´s back between the fore and the hind extremities
- % coverage: approx. 1/10 of body surface
- Type of wrap: 8 layers of gauze covered with a plastic sheet and secured with adhesive plaster
REMOVAL OF TEST SUBSTANCE
- Washing: not applicable
TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before and immediately, 5, 15, 30 and 60 min as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs observed.
- Gross pathology:
- No macroscopical changes were noted at necropsy.
- Other findings:
- - Organ weights: not examined
- Histopathology: not examined - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test item revealed a dermal LD50 of > 2000 mg/kg bw in the rat.
- Executive summary:
Acute dermal toxicity of the test item was assessed according to OECD TG 402. A single dermal administration of 2000 mg test item / kg bw to 5 male and 5 female rats did not reveal any clinical signs of toxicity nor mortality. No skin reactions were observed. The animals gained the expected weight throughout the whole study period. Therefore, the acute dermal LD50 was determined to be > 2000 mg/kg bw.
Reference
Table 1 Summarized Results: 2000 mg test item / kg bw
Symptoms/Criteria |
Males (n=5) |
Females (n=5) |
Clinical signs |
none |
None |
Skin reactions |
none |
None |
Mortality Within 6 h Within 24 h Within 7 d Within 14 d |
0 |
0 |
Mean body weight (in g) |
||
Start |
239.6 |
207.0 |
After 7 days |
295.2 (+23.1) |
253.2 (+12.6) |
After 14 days |
360.0 (+50.1) |
248.6 (+20.1) |
Inhibition of body weight gain |
None |
None |
Necropsy findings |
None |
None |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline study.
Additional information
Acute oral toxicity, OECD 420
The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001. The study was initiated with a sighting study, in which one female rat was given the test item in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Based on the results from the sighting study the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment and showed signs of toxicosis ranging from slight to moderate.
Acute dermal toxicity, OECD 402
Acute dermal toxicity of the test item was assessed according to OECD TG 402. A single dermal administration of 2000 mg test item / kg bw to 5 male and 5 female rats did not reveal any clinical signs of toxicity nor mortality. No skin reactions were observed. The animals gained the expected weight throughout the whole study period. Therefore, the acute dermal LD50 was determined to be > 2000 mg/kg bw.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data, the test item does not require classification as acutely
toxic via the oral or dermal route according to Regulation (EC) No
1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No
2017/776.
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