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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:
2011-11-09 to 2011-11-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance 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 and done to a valid guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only single dose used
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
other: EC 440/2008
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Dark Brown Liquid
Specific details on test material used for the study:
EC Number: 939-946-2

Test animals

Species:
rat
Strain:
other: CRL:(W1) BR Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Species and strain: CRL:(WI) BRWistar rats
Hygienic level at arrival: SPF
Hygienic level during the study: Standard housing conditions
Justification of strain: Recognized by international guidelines as a recommended test system
Number of animals: 5 animals/sex
Sex: Male and female, female rats were nulliparous and non- pregnant
Age of animals: Young adult rats
Body weight range
at dosing: Between 207 g and 256 g
Acclimatization time: 6 days
Husbandry
Animal health: Only healthy animals were used for the study. The veterinarian certified the health status.
Room-Box: 242/1
Housing: Individual caging
Cage type: Type II. polypropylene/polycarbonate
Bedding: Laboratory bedding was available to animals during the study
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 15 - 20 air exchanges per hour
Enrichment: Rodents are housed with deep wood sawdust bedding to allow digging and other normal rodent activities.
The temperature and relative humidity were recorded twice daily during the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
The backs of the animals were shaven (approximately 10% area of the total body surface) approximately 24 hours prior to treatment. Only those animals without injury or irritation on the skin were used in the test.
On test day 0, the test item was applied at a single dose of 2000 mg/kg body weight applied uniformly over the skin and remained on the skin throughout a 24- hour exposure period. Sterile gauze pads were placed on the skin of rats at the site of application. These gauze pads were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using body temperature water.
Duration of exposure:
24 hours
Doses:
single dose 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Single dermal semiocclusive dose at 2000 mg/kg to a group of 5 male and 5 female rats for a 24 hour exposure period.
Statistics:
No specific statistics used

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No clinical signs observed
Body weight:
No bodyweight effects observed
Gross pathology:
No treatement related macroscopic findings were observed

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The median lethal dose after single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) BR Wistar rats.
The study is considered to be relevant, reliable, adequate for risk assessment, and adequate for classification purposes.
Executive summary:

A single administration at a dose of 2000 mg/kg body weight was applied dermally to 5 male and 5 female CRL:(WI) BR Wistar rats, followed by a 14-day observation period. The test item was applied as supplied by the Sponsor. The application period was 24 hours.

Clinical observations were assessed in all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. All animals were euthanized and subjected to a gross macroscopic examination at the end of the 14-day observation period (Day 14).

Results

No mortality occurred during the study.

No adverse clinical signs were observed after treatment with the test item or during the 14 day observation period. Erythema was noted on the skin in all animals after dosing from Day 1 up until Day 2 (for one animal), Day 3 for 7 animals, Day 4 for one animal and Day 5 in another.

There were no effects on body weight or body weight gain during the observation period.

There were no treatment-related observations at necropsy.

Conclusion

The median lethal dose of the substance after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) BR Wistar rats.