Registration Dossier

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC Methods for the Determination of Toxicity and Other Health Effects Directive 440/2008/EC Method B.3 (2008)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Test material form:
liquid
Details on test material:
- Purity: 100%

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 9 weeks old
- Weight at study initiation: 302.5-321.8 g for males and 210.7-227.0 g for females
- Housing: Animals were housed individually in solid-bottom caging with bedding and appropriate species-specific enrichment.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-26°C
- Humidity: 30-70%
- Photoperiod: 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal skin
- % coverage: 10% of the total body surface area of rats
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Excess test substance was washed from the dorsal skin of each rat with paper towels soaked in warm water, and the skin was dried.
- Time after start of exposure: Approximately 24 hours

TEST MATERIAL
- Amount applied: 5000 mg/kg (neat)
Duration of exposure:
24 h
Doses:
5000 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: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, and abnormal behavior. The rats were weighed on test days 1, 8, and 15, and were observed daily for clinical signs of toxicity and dermal irritation (weekends and holidays excluded for dermal irritation).
- Necropsy of survivors performed: Yes, all rats were euthanized at the end of the 15-day test period and examined to detect grossly observable evidence of organ or tissue damage.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no instances of mortality at 5000 mg/kg
Clinical signs:
There were no clinical abnormalities or other signs of skin irritation
Body weight:
There were no overall body weight losses
Gross pathology:
No gross lesions were present in the rats at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Dermal LD50: >5000 mg/Kg bw (male and female rats)
Executive summary:

A single dose of the test substance was applied to the shaved, intact skin of 5 male and 5 female rats at a dose level of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage at the end of the 15-day test period.

There were no incidents of mortality, no overall body weight losses, and no clinical abnormalities or other signs of skin irritation observed during the study. No gross lesions were present in the rats at necropsy.

Under the conditions of this study, the dermal LD50 for the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.