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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:
5 June 2007 to 19 June 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Cellcore MX
- Physical state: solid
- Appearance: black powder
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: CD (Crl:CD (SD) IGS BR)
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 225 - 242 g (males); 209 - 224 g (females). The weight variation did not exceed ± 20 % of the mean weight for each sex.
- Housing: the animals were housed in suspended solid floor 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.
- Diet: ad libitum Certified Rat and Mouse Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 25 °C
- Humidity (%): 30 – 70 % (relative)
- Air changes (per hr): at least 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light (06:00 to 18:00)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Remarks:
The test material was moistened with distilled water prior to application.
Details on dermal exposure:
On the day before treatment the back and flanks of each animal were clipped free of hair.

The appropriate amount of test material, moistened with distilled water, was evenly applied over an area of shorn skin (approximately 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 self-adhesive bandage. 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 a suitable vehicle to remove any residual test material.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed for mortality and clinical signs of toxicity ½, 1, 2 and 4 hours after dosing and daily thereafter. After removal of the dressings and subsequently once daily for the 14 day observation period, the test sites were examined for evidence of primary irritation.
- Frequency of weighing: individual body weights were recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes. Animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: any other skin reactions, if present, were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
All animals gained weight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Dermal reactions
Grey coloured staining was noted at all treatment sites one and two days after dosing and at the treatment sites of all males on day 3. However, there were no signs of dermal irritation; the skin reactions for all animals at all observation times were awarded a score of 0.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the acute dermal LD50 value of the test material was determined to be in excess of 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test material was investigated in the Sprague-Dawley CD strain rat in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 402 and EU Method B.3.

During the study, a group of 5 male and 5 female rats received a single dermal application of test material at a dose of 2000 mg/kg bw. The test material was held in contact with the animals’ skin for a period of 24 hours, under a semi-occlusive dressing. Clinical signs and body weight development were monitored during the study and all animals were subjected to gross necropsy.

None of the animals died during the study, no clinical signs of toxicity were noted and no signs of dermal irritation were observed at the treatment sites. All of the animals gained weight during the study and no gross abnormalities were noted at necropsy.

Therefore, under the conditions of the study, the acute dermal LD50 value of the test material was determined to be in excess of 2000 mg/kg bw and as such the test material requires no classification in accordance with EU criteria.