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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: Study conducted according to internationally accepted testing guidelines; the deviations do not impair the result's reliability.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf.
- Age at study initiation: males: 10 weeks; females: 12 weeks.
- Weight at study initiation: males: 228 - 234 g; females: 198 - 206 g.
- Housing: individually in Makrolon type-2 cages with standard softwood bedding.
- Diet: Kliba 343, Batches 77/90 and 78/90 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) ad libitum.
- Water: community tap water from Itingen, ad libitum.
- Acclimation period: 1 week.
Only those animals with no signs of skin injury or irritation were used in the experiment.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Photoperiod: 12/12 hrs dark / hrs light.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 24 hours before treatment, the backs of the animals were clipped with an electric clipper.
- % coverage: approximately 10 % of the total body surface.
- Application: on test day 1, the test article was applied evenly on the skin with a syringe and covered with a semi-occlusive dressing.
- Type of wrap if used: the dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water, dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amountapplied: 4 ml/kg body weight was applied to the test site, for a dose of 2000 mg/kg
- Concentration: 0.5 g/ml
- Constant volume or concentration used: yes
Duration of exposure:
24 hours after the application, the dressing was removed.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: four times during day 1, and daily during days 2-13. Skin reactions were assessed on removal and after 48 and 72 hours and 4 and 7 days.
- Frequency of weighing: test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
No systemic signs were observed in the animals during the entire observation period.
Local symptoms: all animals had a discoulored skin (yellow), and 1 male showes scales at the back. All animals had recovered from the local signs after 8 observation days.
Body weight:
One female lost slightly weight between day 1 and 8 of the test period. The body weight gain of the further animals was not affected throughout the
study by test article treatment.
Gross pathology:
No macroscopical organ findings were observed in the animals.
Other findings:
IRRITATION
Well defined erythema (grade 2) was observed in all animals after 24 hours, as well as in 4/6 animals at 48 and 72 hours. After 24, 48 and 72 hours, the erythema scores were 2.0, 1.7 and 1.7. Except for one slight edema (grade 2) in one male after 48 hours, only very slight edema (grade 1) was observed in some animals after 24, 48 and 72 hours. After 24, 48 and 72 hours, the edema scores were 1.0, 0.7 and 0.5, respectively.
All effects were fully reversible within 7 days (all scores: 0.0). There was no staining of the treated skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information According to the CLP Regulation. Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw.
Executive summary:

Method

Upon an acute oral single administration (2000 mg/kg bw) and a 14 day post-treatment observation period, the dermal LD50 was determined for the test substance, according to the OECD guideline 402.

Results

LD50 > 2000 mg/kg bw.

No systemic signs were observed in the animals during the entire observation period.

All animals had a discoulored skin (yellow), and 1 male showes scales at the back. All animals had recovered from the local signs after 8 observation days.