Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Remarks:
GLP statement
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Langshaw Farms, Augusta, Michigan
- Age at study initiation: 'young' - no age specified
- Weight at study initiation: approximately 2.0 kg
- Fasting period before study: not specified
- Housing: individually in clean stainless steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room. Specifics not stated.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal body surface of the trunk
- % coverage: not stated
- Type of wrap if used: impervious plastic cuff held in place a cloth bandage taped to the hair

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration (if solution): 2.0 g/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 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
- Frequency of observations and weighing: weighed 24 hours, 7 days and 14 days post test material application. Degree of skin irritation 30 minutes and 72 hours after washing
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths
Clinical signs:
None
Gross pathology:
No compound related gross pathological alterations
Other findings:
Very slight (Grade 1) erythema in 7/10 animals examined 30 minutes after 24 hour exposure. No visible signs of irritation in any animal 72 hours post-exposure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study, the test substance was tested in a limit test conducted according to a test guideline equivalent to OECD TG 402. Single dermal administration at 2000 mg/kg to five male and five female rabbits did not result in mortality. The acute dermal LD50 was therefore established to be greater than 2000 mg/kg in this study. Furthermore, the substance was judged to not meet the EU criteria for classification as a skin irritant.