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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:
supporting study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd., Switzerland
- Age at study initiation: males 9 weeks, females 12 weeks
- Fasting period before study: not reported
- Housing: During acclimation, in groups of 5/sex in Makrolon type 4 cages. Individually in Makrolon type-3 cages during treatment and observation.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for htis study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the back
- % coverage: 10
- Type of wrap if used: Semi-occlusive dressing was wrapped around the abdomen, and fixed with an elastic adhesive bandage.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Mortality and viability were observed once daily during acclimatization period and 1, 2, 3 and 5 hours after test item administration on test day 1 and twice daily during days 2-15. Each animal was examined for changes in appearance and behaviour once daily during the acclimatization phase. 1, 2, 3 and 5 hours after test item administration on test day 1, and once daily during days 2-15. All abnormalities were recorded. Body weights were recorded on days 1, 8 and 15.

- Necropsy of survivors performed: yes

Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
other: Reversible slight to moderate reddening (maculated), scaling, and scabbing were noted at the application in 6, 2 and 3 animals respectively. All dermal reactions subsided by day 10. No other clinical signs were observed during the observation period.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the acute dermal toxicity study, conducted according to OECD Test Guideline 402 and in compliance with GLP, the concluded LD50 value was >2000 in male and female rats.