Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1st November - 15th November 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed to GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: Charles River (UK) Ltd
Environmental conditions:
Housed individually during the 24 hour exposure period and then in groups of 5 by sex in suspended solid floor cages furnished with wood flakes for the remainder of the study.
Temperature: 19-25ºC
Humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food throughout the study

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: None
Details on dermal exposure:
On the day before treatment the back and flanks of each animal were clipped free of hair.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male, 5 female
Control animals:
not specified
Details on study design:
The calculated volume of test material was applied as evenly as possible to an area of shorn skin (approximatley 10% of the total body surface area) using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-hour exposure period. After 24 hours the bandage was careully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were observed for overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
None
Body weight:
All animals showed expected bodyweight gain over the study period.
Gross pathology:
Effects on organs:
All animals were killed after 14 days observation. There
were no abnormalities noted at necropsy.
Other findings:
Signs of toxicity (local):
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A GLP study was performed in accordance with OECD method 402 in order to assess the acute dermal toxicity of Inhibitor AHM P500 to the Sprague-Dawley CD strain rat.

A group of ten animals (5 males, 5 females) was given a single, 24 hour semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subject to gross necropsy.

No deaths or signs of systemic toxicity were observed during the course of the study. There were no signs of dermal irritation and all animals showed expected bodyweight gain over the study period.No abnormalities were noted at necropsy

The acute dermal median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight