Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 402), some minor deviations from guideline

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
Remarks:
RCC, Research & Consulting Company AG
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Solid
- Analytical purity: 83%
- Lot/batch No.: EN 20
- Stability under test conditions: Stable; expiration date: January 1, 1992
- Storage condition of test material: In the original container, protected from light in refrigerator (approx. 4°C).

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


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


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Type of wrap if used: 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
- Amount(s) applied (volume or weight with unit): Four ml/kg body weight was applied to the test site, for a dose of 2000 mg/kg
- Concentration (if solution): 0.5 g/ml
- Constant volume or concentration used: yes
Duration of exposure:
24 h
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
- 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.

Any other information on results incl. tables

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, respectively (intact skin). 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 (intact skin). The total of all scores, i.e. for intact AND abraded skin, was 9.3. The primary irritation index (for abraded AND intact skin) was 2.33, which was listed as being in the moderate range (2.1-4.0). 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 Criteria used for interpretation of results: EU
Conclusions:
The substance is not acute toxic via dermal application.