Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conducted in accordance with modern guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Animals were caged in groups (by sex) during the post-dosing observation period
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
Animals were caged in groups (by sex) during the post-dosing observation period
GLP compliance:
yes (incl. certificate)
Test type:
other:
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number: E0011-039E

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Age at study initiation: 8–12 weeks
- Weight at study initiation: At least 200g. Weight variation did not exceed +/- 20% of the mean weight for each sex.
- Fasting period before study: No.
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Yes.
- Water (e.g. ad libitum): Yes.
- Acclimation period: At least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19–25
- Humidity (%): 30–70
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 31/01/08 To: 14/02/08

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure: Back and flanks
- % coverage: Approximately 10%
- Type of wrap if used: Surgical gauze semi-occluded with a piece of self-adhesive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated skin and surrounding hair wiped with cotton wool moistened with distilled water.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2,000 mg/kg bodyweight
- Concentration (if solution): N/A
- Constant volume or concentration used: no.
- For solids, paste formed: Not stated, but test material was moistened with arachis oil


VEHICLE Test material was moistened with arachis oil BP
- Amount(s) applied (volume or weight with unit): Unknown
- Concentration (if solution): Not applicable.
- Lot/batch no. (if required): Unknown.
- Purity: Unknown.
Duration of exposure:
24 hours
Doses:
2,000 mg/kg bodyweight
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 : Observations were made at 0.5, 1, 2 and 4 hours after test material application and daily thereafter.
- Frequency of weighings: Bodyweights were measured prior to test material application (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
Statistics:
The LD50 was estimated.

Results and discussion

Effect levels
Remarks on result:
other: There were no deaths
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs of toxicity were oberved.
Body weight:
No effects on bodyweight gain were oberved.
Gross pathology:
No gross pathology was observed.
Other findings:
No indications of dermal irritation were observed.

Applicant's summary and conclusion

Conclusions:
The test material caused no mortality or signs of toxicity in this study. The acute dermal LD50 of the test material in Sprague-Dawley CD rats is greater than 2,000 mg/kg bodyweight.
Executive summary:

An acute dermal toxcity study (limit test) was conducted in Sprague-Dawley CD rats using a dose of 2,000 mg of test material (moistened with arachis oil BP) per kg bodyweight, applied under semi-occlusive dressing for 24 hours and followed by a 14 -day observation period. This GLP study was conducted in accordance with OECD Test Guideline 402, except that, following removal of the test material, animals were group-housed (by sex), but this is not considered to have affected study reliability.

No animals died during the study and no signs of toxicity or adverse effects were observed in-life or at necropsy. The LD50 of the test material in Sprague-Dawley rats is concluded to be >2,000 mg/kg bodyweight.