Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-11-24 to 1997-12-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 200 to 212 g (males), 200 to 230 g (females)
- Fasting period before study: none
- Housing: individually during the 24-h exposure and in groups of five, by sex, for the remainder of the study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22
- Humidity (%):50 to 72
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a pice of self-adhesive bandage. The bandage was further secured with a piece of BLENDERM wrapped around each end

REMOVAL OF TEST SUBSTANCE
- Washing: The treated skin and surrounding hair were wiped with cotton wool moistened with arachis oil BP .
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: yes (test material was moistened with arachis oil)


Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5 males per dose
5 females per dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, 4 hours after dosing and subsequently once daily for 14 days
- Day 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions, body weight, necropsy
Statistics:
none

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:
None
Clinical signs:
No signs of systemic toxicity.
Body weight:
All animals showed an expected gain in bodyweight.
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material, TODI, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 Frebruary 1987) and Method B3 of Commision Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A group of ten animals (fivel males and five females) was given a single 24 -hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study. Very slight to well-defined erythema was noted at the treatment sites of eight animals one day after dosing. No other signs of skin irritation were noted during the study.

All animals showed an expected gain in body weight during the study.

No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg body weight.