Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

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))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Remarks:
Granular white powder
Details on test material:
Granular white powder
Specific details on test material used for the study:
Sponsor’s identification : CJ-11,972
Description : white solid
Batch number : 52855-l 6-4
Date received : 11 April 2001
Storage conditions : room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Five male and five female Sprague-Dawley CD (Crl: CD@ (SD) IGS BR) strain rats were supplied
by Charles River (UK) Ltd, Margate, Kent, UK. On receipt the animals were randomly allocated
to cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at
least five days the animals were selected at random and given a number unique within the study
by indelible ink-marking on the tail and a number written on a cage card. At the start of the study
the animals weighed at least 200g, and were approximately eight weeks of age.
The animals were housed in suspended polypropylene cages furnished with woodflakes. The
animals were housed individually during the 24-hour exposure period and in groups of five, by
sex, for the remainder of the study. Free access to mains drinking water and food (Rat and Mouse
SQC Expanded Diet No. 1, Special Diets Services Limited, W itham, Essex, UK) was allowed
throughout the study. The diet, drinking water and bedding were routinely analysed and were
considered not to contain any contaminants that could reasonably be expected to affect the
purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70%
respectively. Any occasional deviations from these targets were considered not to have affected
the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per
hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00
to 18:00) and twelve hours darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day before treatment the back and flanks of each animal were clipped free of hair.
A group of five male and five female rats was treated with the test material at a dose level of
2000 mg/kg.
The appropriate amount of test material, moistened with distilled water, was applied as evenly as
possible to an area of shorn skin (approximating to 10% of the total body surface area). A piece
of surgical gauze was placed over the treatment area and semi-occluded with a piece of selfadhesive bandage.
The animals were caged individually for the 24-hour exposure period. Shortly after dosing, the dressings were examined to ensure that they were securely in place.
After the 24-hour contact period the bandage was carefully 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 returned to group housing for the remainder of the study period.
Duration of exposure:
After the 24-hour contact period the bandage was carefully 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 returned to group housing for the remainder of the study period.
Doses:
2000mg/kg bw
No. of animals per sex per dose:
five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ‘/, 1, 2 and 4 hours after dosing and subsequently at least once daily for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: skin irritation
Statistics:
N/A

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LDw) of the test material, in the Sprague-Dawley CD (Crl:
CD@ (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.
The test material does not meet the criteria for classification and will not require labelling for
dermal toxicity in accordance with EU labelling regulations Commission Directive 93/21/EEC
and subssequently 1272/2008/EC.