Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house
- Age at study initiation: young adult
- Weight at study initiation: 209 to 247 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 + 10 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.

The test article was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly,
Duration of exposure:
24 hours
Doses:
2000 mg/kg
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
- Frequency of observations and weighing: Observed for mortality daily, a.m. and p.m. on working days, a.m. on weekend days. Observed for signs and symptoms daily.
- Body weights: immediately before application and on days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
Not needed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities occurred in this study.
Clinical signs:
Piloerection was observed in males and females on the day of application. At the application site, erythema was observed in the females followed by slight necrosis.
Females recovered within 14 days.
Body weight:
All animals gained weight throughout the study.
Gross pathology:
No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified by CLP criteria
Conclusions:
In a guideline (OECD 402) rat study, the acute dermal LD50 of Irgastab CH 302 was > 2,000 mg/kg. No mortality occurred during the study.