Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-07-13 to 1995-01-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Crédo, 69210 L'Arbresle, France
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Male: 257 +/- 13 g, Female: 218 +/- 10 g
- Housing: The animals were housed in polycarbonate cages covered with a stainless steel lid.
- Diet: A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water: Drinking water filtered by a F.G. Millipore membrane (0.22 micron) was contained in bottles
- Acclimation period: At least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Area of skin representing 5 x 6 cm for the females and 5 x 7 cm for the males of the body surface of the animals.
- % coverage: 10 %
- Type of wrap if used: A hydrophilic gauze pad (Semes France, 54183 Heillecourt, France)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Evaluation of the innoxiousness or toxicity of the test substance following a single dermal application in rats should include the relationship, if any, between the animals' exposure to the test substance and the incidence and severity of all the abnormalities including behavioural and clinical abnormalities, macroscopic lesions, body weight changes, mortality and any other toxic effects.

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 occurred during the observation period.
Clinical signs:
No clinical signs were observed during the study.
In all males, moderate erythema (grade 2) and slight or moderate oedema (grade 2 or 3) were observed from day 2 to day 4. No sign of erythema or oedema was noted after day 4. Dryness of the skin was observed at the test site from day 3 to day 10. All cutaneous reactions had subsided on day 13.
In females, moderate erythema (grade 2) and slight or moderate oedema (grade 2 or 3) were seen the day after treatment. Oedema (grade 2) persisted in 2 animals only the next day. Moderate to marked erythema persisted in all animals up to day 6. Crusts were noted in 2 females on days 3 and 4 and in all animals on days 5 to 9. Dryness of the skin was observed at the test site on day 5 to day 9 or 12. All cutaneous reactions had subsided on day 13.
Body weight:
Slight decrease in body weight gain was noted in both sexes the first week. The second week, body weight gain was comparable to historical control data from animals of the same age, strain supplier, sex and initial body weight.
Gross pathology:
Macroscopic examination of the main organs of the animals killed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal toxicity of the test item was determined according to OECD guideline 402. The LD50 was determined to be >2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was determined according to OECD guideline 402. The test substance (50 % purity) was applied semi-occlusively to the skin of rats at a dose of 2000 mg/kg bw. 5 males and 5 females showed no mortality after an exposure period of 24 hours and an observation period of 14 days. The LD50 was determined to be > 2000 mg/kg bw. The animals were also checked for clinical signs, body weight gain and necropsy. The general behaviour of the animals was not affected by treatment. Moderate to marked cutaneous reactions were observed in both sexes the first 4 -6 days after treatment. All signs of skin irritation had subsided by day 13.

Slight decreased body weight gain was observed in both sexes the first week only. No death occured at 2000 mg/kg bw. A macroscopic examination revealed no abnormalities in the animals killed at the end of the study.