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Toxicological information

Acute Toxicity: dermal

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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: guideline study according to GLP

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)
Deviations:
yes
Remarks:
Due to the physical-chemical properties, the test substance had to be applied by weight.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid, white
- Analytical purity: > 95%
- 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: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: not specified
- Weight at study initiation: 207 to 273 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland (ad libitum)
- Water: ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Details on dermal exposure:
TEST SITE
- Area of exposure: back of the rat
- % coverage: 10
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied (ml/kg body weight): 4 g (corresponding approximately to 4 ml).
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortalities
Clinical signs:
Piloerection and hunched posture were seen, the animals recovered within 2 days.
Gross pathology:
At necropsy, no deviations from normal morphology were found.

Any other information on results incl. tables

 Animal number Body weights (g) Day 0  Body weights (g) Day 7   Body weights (g) Day 14

 MALES dosed with 2000 mg/kg bodyweight         

 1 264 307   350
 2 273 301  333 
 3 256 290  319 
 4 265 291  317 
 5 260 288  316 
 mean 264 295  327 
 SD 6.3 8.2   14.6

 FEMALES dosed with 2000 mg/kg bodyweight         

 1 254 253 291
 2 232  241  252 
 3 229 247  240 
 4 207 212  235 
 5 221 226  235 
 mean 229 236  251 
 SD 17.2 16.7  23.6 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute dermal LD50 of the test substance in rats of both sexes is greater than 2000 mg/kg body weight.
Executive summary:

Five male and five female (Tif: RAI f (SPF)) rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was diluted in 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 and applied at a dosage of 2 g/kg. The application period was 24 hours. No deaths occurred during the study. Clinical signs were piloerection and hunched posture, being common symptoms in acute dermal tests. No macroscopic findings were observed at necropsy. In conclusion, the median lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.