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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:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.

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)
Deviations:
yes
Remarks:
Collective housing up to a maximum of 5 animals per cage, relative humidity was 50-85%, temperature was 20 ± 2°C.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 7, 8714 Sulzfeld
- Age at study initiation: Not reported
- Weight at study initiation: m: 194-233 g, f: 155-220 g
- Fasting period before study: Not reported
- Housing: Collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet (e.g. ad libitum): Ssniff-R Alleindiat (ad libitum). Ssniff Spezialdiaten GmbH 4770 Soest/Westfalen.
- Water (e.g. ad libitum): Drinking water as for human consumption in drinking bottles (ad libitum)
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 50 - 85%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): artificial lighting from 7am - 7pm (12/12)


Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Oleum arachidis
Details on dermal exposure:
Prior to study initiation, the animals were acclimated to laboratory conditions for at least 7 days. 24 h before treatment, the fur was removed with electric clippers from an area of roughly 5 x 10 cm on the back of each animal. The skin was subsequently examined for abrasions and animals with healthy, intact skin were then marked (in color) for individual identification. The test article was applied as a 20 % dilution in Oleum arachidis. The pH value was 6.5. A single dermal application of the test article was performed. The substance was held in contact with the skin with a porous gauze dressing and ElastoplastR (Beiersdorf). The exposure period was 24 h.
Duration of exposure:
Test article was applied for 24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
not required
Details on study design:
In each animal a number of clinical-toxicological signs were evaluated according to a modified Irwin-Screening procedure. Any change from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed. The animals were examined at the following intervals after treatment: 20 min, 1, 2, 3, 6, and 24 h and thereafter once daily up to day 14. After patch removal, dermal irritation was evaluated once daily for 14 days according to a scheme based on Draize. The body weights of all animals were recorded immediately before treatment (day 0) and surviving animals were reweighed on days 7 and 14 (termination). Animals found dead or killed in extremis were immediately necropsied. The surviving animals were sacrificed by CO2 asphyxiation after 14 days and gross pathological examinations were subsequently performed.

EVALUATION OF SKIN REACTION
(based on Draize):

Erythema and Eschar Formation Value

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Maximum possible = 4

Oedema Formation Value

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined
by definite raising) 2
Moderate oedema (raised approximately 1
millimetre) 3
Severe oedema (raised more than 1
millimetre and extending beyond area
of exposure) 4

Maximum possible = 4

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No pre-terminal deaths occurred
Clinical signs:
No abnormal clinical signs were observed
Body weight:
All animals showed normal weight gains
Gross pathology:
Gross pathological examinations at 14 days p.a (terminal necropsy) revealed no test article-dependent findings.
Other findings:
No other findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute toxicity, Cat. 4, H312