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Administrative data

Description of key information

The acute oral LD50 of the test material was determined to be >5000 mg/kg bw in male and female rats.

The acute dermal LD50 of the test material was determined to be >2000 mg/kg bw in male and female rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4th June 1993 to 18th June 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl:CD(R)BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 219-294 g
- Fasting period before study: 18-20 hours
- Housing: Individual suspended wire-mesh cages
- Diet: ad libitum
- Water: ad libitum (tap water)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 °C
- Humidity (%): 48-90 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were examined for mortality and clinical observations at 1, 3, and 4 hours post dosing on day 0. The animals were observed for mortalty twice daily thereafter (morning and afternoon) and once daily for clinical observations until day 14. Body weights were examined on days -1, 0 (initation), 7 and 14 (study termination).
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no unscheduled deaths during the study
Clinical signs:
All animals demonstrated abnormal defecation (soft stool, diarrhea, mucoid faeces or decreased faeces), wet or dried yellow urogenital/abdominal staining and various dried red stainings around the nose, mount and or forepaws. Six rats had dried or wet yellow staining around the mouth. Wet and/or drid brown urogenital staining was noted for two rats. There were single occurences of hypoactivity and clear wet matting around the mouth. One rat had clear ocular discharge at the 3 and 4 hour post dose observation. There were no other clinical findings. All animals appeared normal on days 13 and 14.
Body weight:
Three rats between the days 0 to 7 lost between 6 and 48 grams. These rats gained weight during the second week of the study, surpassing day 0 body weight by day 14. There were no other significant changes or differences in body weights during the study.
Gross pathology:
One male had small soft testes considered to be a congenital abnormality at the terminal necropsy. No other significant changes observed for all examined tissues at the terminal necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material was determined to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

The acute oral toxicity of the test material was determined in a study performed in accordance with OECD 401, EU Method B.1 and EPA OTS 798.1175. Under the conditions of the test, the LD50 of the test material was determined to be >5000 mg/kg bw in male and female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25th May 1993 to 8th June 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2518 to 2793 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 50-82 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 20 %
- Type of wrap if used: Doses were applied under gauze binders that were secured with tape. Collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with wet disposable paper towels moistened with mineral oil (USP).
- Time after start of exposure: At the end of the exposure period

TEST MATERIAL
- Amount(s) applied: 2.13 mL/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical effects at 1, 3 and 4 hours post dosing on day 0, thereafter animals were observed twice daily (morning and afternoon) for mortality and once daily for clinical observations for the rest of the 14 day observation period. Body weights were measured on days 0, 7 and 14. Dermal observations were performed 30-60 minutes after bandage removal and daily thereafter. The animals were shaved and days 3, 7, 10 and 14 to facilitate observations.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no unscheduled deaths during the study.
Clinical signs:
Vocalisation after handling was noted in one femal of day 2. One female had dried red material around the mouth on day 0 that was considered to be related to the restraining collar. There were no other clinical findings during the study.
Body weight:
There were no remarkable changes or differences in body weights during the study.
Gross pathology:
An accessory spleen was noted for two rabbits terminally necropsied. This is a common congenital abnormality. There were no other gross necropsy findings.
Other findings:
The test material induced moderate to severe erythema and oedema in all rabbits. All sites had desquamation initially on day 4-5. Nine rabbits were hypersensitive to site manipulation during the dirst week of the study. Eschar and subsequent exfoliation were present on six sites by day 7. Fissuring was noted sporadically during the first week of the study for six sites. All sites had very slight to slight erythema and/or oedema and desquamation at study termination (day 14). There were no other dermal findings.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was examined in male and female rabbits in a study conducted in accordance with OECD 402, EU Method B.3 and EPA OTS 798.1100. Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

In accordance with regulation EC 1272/2008 (CLP), the substance is not classified for acute toxicity based on the acute oral LD50 of >5000 mg/kg bw and the acute dermal LD50 >2000 mg/kg bw.