Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Aug. 26, 1981 to Sep. 8, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF strain)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Random bred rats raised on the premises (CIBA-GEIGY Limited, Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: 208 +/-6.7 g for males and 174 +/- 13.8 g for females
- Fasting period before study: Not reported
- Housing: Housed individually in Macrolon cages (type 2)
- Diet (e.g. ad libitum): ad libitum, rat food (NAFAG No. 880, NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Distilled water containing 0.5% carboymethylcellulose and 0.1% Tween 80
Details on dermal exposure:
TEST SITE
- Area of exposure: on the back of the animals
- % coverage: Not reported
- Type of wrap if used: For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mL/kg body weight
- Concentration (if solution): Not reported

Duration of exposure:
24 hours
Doses:
5,000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Signs and symptoms, mortality, and skin irritation parameters (erythema, edema, and necrosis) were observed at 1, 2, 3, 5, and 24 hours, and then daily each day up to a period of 14 days. Body weights were recorded immediately prior to dosing and at 7 and 14 days.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no deaths reported
Mortality:
No deaths were reported.
Clinical signs:
Dyspnea, exophthalmos, ruffled fur and curved body position. These clinical signs are common effects in this type of study. All animals recovered within nine days.
Body weight:
Mean body weights were provided but were not discussed.
Gross pathology:
No gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

In this guideline (OECD 402) comparable study, the acute, dermal LD50 of the test material to rats was determined to be >5000 mg/kg bw. 10 rats (5 male, 5 female) were exposed dermally to the test material (occlusive conditions) for 24 hours, and then observed for 14 days. No mortality was observed, and no treatment related effects were reported. Based upon this test result the test material does not meet the criteria for classification as acutely toxic under the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).