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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
Study period:
Apr. 1, 1992 to Jun. 22, 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)
Deviations:
no
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
- Storage condition of test material: Room Temperature

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited (Animal Production) 4332 stein, Switzerland
- Weight at study initiation: 202 to 229 g
- Housing: Individually housed, in Macrolon cages type 3, with standarized soft wood bedding
- Diet (e.g. ad libitum): ad libitum, NAFAG 890 TOX
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: guaze-lined semiocclusive dressing


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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Constant volume or concentration used: yes (4 mL/kg body weight)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5% carboxymethylcellulose in 0.1% aqueous polysorbate 80

Duration of exposure:
24 hours
Doses:
2,000 mg/kg body weight
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weighing on Day 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Preliminary study:
Limit Test
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
Piloerection was seen, that is a common unspecific clinical sign in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.
Body weight:
normal body weight gain
Gross pathology:
None
Other findings:
Other Observations: No deviation from normal morphology were found upon necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Executive summary:

Upon an acute dermal administration of 24 hours and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for the test item:

LD50 in male rats: greater than 2000 mg/kg body weight

LD50 in female rats: greater than 2000 mg/kg body weight

LD50 in rats of both sexes: greater than 2000 mg/kg body weight

Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 to 3 days. At autopsy, no deviations from normal morphology were found.