Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-08-22 to 2012-09-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DEBR 012553

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: 274-282 g (male), 239-265 g (female)
- Housing:animals were housed individually.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 47 days (females) and 5 days (males)

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr):8-12 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 am. to 6 pm

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: approximately 10 % of the total body surface area
- Type of wrap if used: semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing:using body temperature water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied:The test item was uniformly applied in a single dose to at least 10 % of the total body surface area
- For solids, paste formed: yes

Duration of exposure:
24 hours
Doses:
Pretest: 5, 50, 300 and 2000 mg/kg bw dose levels, Maintest: 2000 mg/kg bw
No. of animals per sex per dose:
Pretest: 2 female animals
Maintest: 5 female and 5 male animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs: individually 1 h and 5 h after dosing, and once each day for 14 days
Body weight: shortly before treatment (pretest) and shortly before treatment, on day 7 and on day 15 (maintest)

- Other examinations performed: gross pathology

Results and discussion

Preliminary study:
There were no deaths in preliminary study at 5, 50, 300 and 2000 mg/kg bw dose levels
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema, wounds and crusts that was fully reversible at the end of the 14-day observation period.
Body weight:
Slight body weight loss was observed in one female on first week. It could not be evaluated as a toxic effect of test item.
The body weight development was undisturbed in all male animals.
Gross pathology:
No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present acute dermal toxicity study with the test item Crotonic acid, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.