Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 11, 2010 to May 25, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Source: Covance Research Products, Inc., Denver
Acclimation: 7 days
Body weights: 2.6 - 3.0 kg for males and 2.9 - 3.3 kg for females
Diet: Fresh PMI Rabbit Chow
Water: ad libitum
Light changes: 12h / 12h
Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
To obtain a paste
Details on dermal exposure:
10% of the total body surface (clipped free of hair)
Amount: 3.5 mL
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The test substance was kept in contact with the skin for 24 h. Dermal responses at test sites were recorded at 24 h postdose and on days 7 and 14 using the numerical Draize scoring. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 h after application and once daily for 14 days. All animals were observed twice daily for mortality. Body weight were recorded pretest, weekly and at termination. Finally, rabbits were examined for gross pathology.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the dermal application
Clinical signs:
Instances of few feces were observed in one animal. There were no other abnormal signs noted during the observation period. Neither erythema nor oedema was detected.
Body weight:
Body weight changes were normal.
Gross pathology:
Necropsy results were normal.
Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the study conditions, the rabbit dermal LD50 was determined to > 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute dermal toxicity of the test substance, 'di-C18-22 AAEMIM-MS' (active: 100%), according to OECD Guideline 402, in compliance with GLP. Five male and five female New Zealand White rabbits were exposed to 2000 mg/kg bw test substance (3.5 mL in water) under a semi-occlusive type of coverage on a clipped skin free of hair. The test substance was kept in contact with the skin for 24 hours. Dermal responses at test sites were recorded at 24 h postdose and on days 7 and 14 using the numerical Draize scoring. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours after application and once daily for 14 days. Mortality was checked twice daily. Body weight was recorded pre-test, weekly and at termination. Finally, rabbits were examined for gross pathology. All animals survived the dermal application. Instances of few faeces were observed in one animal. There were no other abnormal signs noted during the observation period. Neither erythema nor oedema was detected. Body weight changes and gross examination were normal. Under the study conditions, the rabbit dermal LD50 was determined to > 2000 mg/kg bw (MBRL, 2010).

 

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion