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:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to
Guideline:
other: EEC Methods for the Determination of Toxicity Method B.3 Directive 92/69/EEC
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes
Test type:
other: Single-dose acute dermal
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 28 wt%

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: Range of 299 – 340 grams for males; range of 202 – 235 grams for females.
- Fasting period before study: Not reported
- Housing: Singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd's™ Cob + PLUS™).
- Diet (e.g. ad libitum): PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area.
- % coverage: approximately 5 cm x 7.4 cm (approximately 37 square centimetres), approximately 10% of the body surface.
- Type of wrap if used: The test substance was covered with a 2-ply gauze pad. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with warm water, and the skin was dried.
- Time after start of exposure: After 24 hours of exposure to the test substance.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight of the test substance. The dose for each animal was corrected for purity.
- Constant volume or concentration used: yes
Duration of exposure:
Animals were exposed to the test substance for 24 hours. Animals were observed for 14 days.
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body Weights – Individual body weights were recorded prior to test substance application (test day 0) and on test days 7 and 14.
Observations – Rats were observed for clinical signs of toxicity and dermal response following test substance removal. Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation) for 14 days.
- Necropsy of survivors performed: Yes.
- Other examinations performed: Pathology examination, grossly observable evidence of organ or tissue damage.
Statistics:
No.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortalities occurred. All animals survived exposure to the test substance.
Clinical signs:
No clinical signs of systemic toxicity were observed. No erythema or oedema was observed on the test site of any rat. Hyperkeratosis was observed on the test site of 3 female rats on test days 6 and 7, and epidermal scaling was observed on the test site of 2 of these rats on test day 8.
Body weight:
No biologically important body weight losses were observed.
Gross pathology:
No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (rats) > 5000 mg/kg
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application. A single dose of five thousand milligrams of the test substance per kilogram of body weight was applied to the skin of 5 male and 5 female rats. The dose for all rats was corrected for the test substance purity. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed, and the rats observed for clinical signs of toxicity and dermal response. Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation) for 14 days. Individual body weights were recorded prior to test substance application (test day 0) and on test days 7 and 14. Necropsies were performed on all animals at terminal sacrifice. No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or biologically important body weight losses during the study. No erythema or oedema was observed on the test site of any rat. Hyperkeratosis was observed on the test site of 3 female rats on test days 6 and 7, and epidermal scaling was observed on the test site of 2 of these rats on test day 8. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the dermal LD50 for the test substance corrected for purity was greater than 5000 mg/kg for male and female rats.