Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 October 1997 to 16 October 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Gel All DX
- Substance type: white powder
- Physical state: solid
- Lot/batch No.: 4073003
- Storage condition of test material: room temperature

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: 8 to 12 weeks
- Weight at study initiation: males: 215 to 243 g; females: 208 to 230 g
- Housing: animals were housed in suspended polypropylene cages furnished with wood flakes. The animals were housed individually during the 24-h exposure period and in groups of 5, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 °C
- Humidity (%): 50 to 74 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/ 12
- On one occasion the relative humidity was above the limit specified in the protocol (70 %). This deviation was not considered to affect the purpose or integrity of the study.

Administration / exposure

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

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair was wiped with cotton wool moistened with arachis oil BP to remoe any residual test material.
- Time after start of exposure: 24 h

TEST MATERIAL
- The test material, as received, was applied uniformly to an area of shorn skin which had been previously moistened with arachis oil BP.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/ sex/ dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 h after dosing and subsequently once daily for 14 aysd. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: dermal reactions (scored according to the Draize scale).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed an expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Dermal reactions: No signs of skin irritation were noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal toxicity of the test material was assessed according to OECD guideline 402. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
Executive summary:

A study was performed to assess the actue 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" and Method B3 of Commission Directive 92/69/EEC.

A group of 10 animals (5 males and 5 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 14 days after the day of treatment and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.

All animals showed an expected gain in bodyweight 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 > 2000 mg/kg bodyweight.