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:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Remarks:
The study was conducted according to the test guidelines in effect at the time of study conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 15.65% solids in water

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: Male average weight - 318.7 g; Female average weight - 223.0 g
- Fasting period before study: no
- Housing: individually in solid-bottom caging
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6-day quarantine period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26ºC
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The area to be treated (approximately 5 cm x 7.4 cm) was marked on the dorsal skin of each rat with a water-insoluble marker. The aliquot of test substance designated for an animal was spread evenly, directly on the skin, covering an area of approximately 37 square centimeters.
- Type of wrap if used: The test substance was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: Approximately 24 hours after treatment

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation).
- Frequency of weighing: The rats were weighed prior to treatment (test day 1) and on test days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality in either sex.
Clinical signs:
The rats exhibited no clinical signs of systemic toxicity during the study.
Body weight:
No body weight loss occurred.
Gross pathology:
No dermal irritation was observed. No gross lesions were present in the rats at necropsy.
Other findings:
A wound observed on the back of one female rat during the study was considered to be incidental and not test substance related.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 > 5000 mg/kg aqueous dispersion or >1000 mg a.i./kg of the multi-constituent substance
Executive summary:

A single dose of the test item was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application. The rats were necropsied to detect grossly observable evidence of organ or tissue damage at the end of the 15-day test period.

No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or body weight loss. No dermal irritation was observed. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the skin absorption LD50 for the test item was > 5000 mg/kg aqueous dispersion or >1000 mg a.i./kd of the multi-constituent substance for male and female rats.