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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:
Oct - Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Regulation (EC) No 1907/2006
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay, Labor fuer biologische Analytik GmbH
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: young adult animals (male approx. 8 weeks, female approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight, actual weights)
- Housing: single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing: yes (rinsing of the application site with warm water)
- Time after start of exposure: 24 hours after Application
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
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 and weighing: Clinical oberservation: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Very slight to severe erythema (grade 1 to 4). Very slight to moderate edema (grade 1 to 3). Incrustations. Severe scaling. Additionally, all local signs were noted beyond the application site.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Any other information on results incl. tables

Under the conditions of this study the median lethal dose (LD50) of Laurylacrylate 1214 after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

The following test item-related effects were recorded during the course of the study:

- No mortality occured

- No signs of systemic toxicity

- Very slight to severe erythema (grade 1 to 4)

- Very slight to moderate edema (grade 1 to 3)

- Incrustrations

- Severe scaling

- Additionally, all local signs were noted beyond the application site.

- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week...

- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw in rats.