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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:
04 July 2006 - 18 July 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical product

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Young healthy adult rats, age not reported, 13 days of acclimatisation; weight range: male 249-258 g, female 201-220 g; husbandry: individual caging at 12 h light and 12 h dark, 19-25°C, 30-70% relative humidity.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A limit test was carried out involving a dose of 2000 mg/kg bw with five malev and female animals each.
A single dermal dermal administration followed by a 14-d observation period was performed.
One day before the start of the test the trunk of the animals was shaved. The test item was applied in pure form in a single dose on about 10% of the total body surface for 24 h. Sterile gauze pads were placed on the skin of the rats and kept in contact with the skin by hypoallergenic plaster. Then the entire trunk of the animal was wrapped with semiocclusive plastic wrap for 24 hours. At the end of the exposure period, resuidual test item was removed by using water with body temperature.
Duration of exposure:
24 hours single exposure
Doses:
On single dosis: 2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
Clinical observations were done for 14 days: 1 h and 5 h after the end of exposure and once a day on the following days.
Individual observations were done on the skin, fur, eyes, mucous membranes, respiration, circulation, autonomic and central nervous system, somatomotoric activity and behaviour.
Body weight was determined at the start (day 0) and on days 7 and 14.
Gross necropsy was performed on all animals after 14 days. External appearance and abnormalities of the organs in the cranial, thoracic and abdominal cavities were recorded.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in this test.
Clinical signs:
No dermal changes in male rats.
Female rats: erythema (5/5), epithelisation (5/5), necrosis (1/5). After 9-11 days, the skin in 4 of 5 animals returned to normal.
Body weight:
The mean body weight and the body weight gain were in the normal range during the observation period.
Gross pathology:
Pinprick-sized haemorrhages in the lungs (male 3/5, female 3/5) were observed.
One female had scar on the site of administration due to test item.
Other findings:
Behaviour and general state of male and female animals were normal during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
AFLAMMIT SAP does not fulfill the criteria for classification and labelling according to the Commission Directive 2001/59/EC.
AFLAMMIT SAP was ranked into the WHO toxic class II-III (moderately/slightly hazardous).
AFLAMMIT SAP was ranked into the EPA toxci class III ("Caution").
Because of the skin effects (one animal showed necrosis and scar at the end of the recovery period) classification with "corrosive, R34" is considered to be necessary.
Executive summary:

A acute dermal toxity test was performed on the test item AFLAMMIT SAP using Wistar rats.The test item was applied in one dose (2000 mg/kg bw) for 24 hours followed by a 14 day observation period.

No mortalities occured in male and female rats (five male and five female): LD50 > 2000 mg/kg bw.

Symptoms in the skin were observed only in female rats and were reversible after 11 day with the exeption of one female rat, which showed necrosis and scar on the treated skin at necropsy.

Pinprick-size haemorrhages were observed in 3 of male and 3 of 5 female rats by necropsy after 14 days.

AFLAMMIT SAP does not fulfill the criteria for classification adn labelling according to the Commission Directive 2001/59/EC.

AFLAMMIT SAP was ranked into the classes WHO II-III (moderately/slightly hazardous) and EPA III ("Caution").