Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-conducted study performed under GLP with certificate. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Animals were housed under standard laboratory conditions. Rooms were air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70% (values above 70% during cleaning process were possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding (‘Lignocel’ J. Rettenmaier & Söhne GmbH & Co. KG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) during treatment and observation.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 58/09 (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum.
Results of respective analyses for contaminants are included in the study report.
Water: Community tap water from Itingen was available ad libitum. Results of bacteriological assay, chemical and contaminant analyses of respective samples are included in the study report.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10% of the total body surface. Only those animals without injury or irritation on the skin were used in the test.

On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly to a moistened surgical gauze pad (ca. 5 x 5 cm), placed on the exposed site and held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and an elastic adhesive restrainer bandage wrapped around the abdomen. The test item will remain in contact with the skin for 24 hours. Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried off with disposable paper towels. Thereafter, the exposure sites
were assessed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
Viability / Mortality: Daily during the acclimatization period, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with clinical signs) and twice daily during days 2 - 15.
Clinical Signs: Daily during the acclimatization period, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1, then once daily during days 2 - 15.
Local Dermal Signs: Once daily during days 2 (following dressing removal) through day 15 using the numerical scoring system described elsewhere in the study report.
Body Weights: On test days 1 (prior to administration), 8 and 15.
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limit test
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were evident during the course of the study.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopical changes were evident at necropsy.
Other findings:
Slight desquamation was noted in one male on the observation days 7 and 8.
No dermal changes were seen in the females.

Applicant's summary and conclusion

Conclusions:
The acute dermal LD50 of erucamide (112-84-5) in rats is >2000 mg/kg.
Executive summary:

Five male and five female RccHan:WIST (SPF) rats were treated with erucamide at 2000 mg/kg by dermal application. The test item was applied to a gauze patch moistened with water. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 - 15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. Slight desquamation was noted on day 7 - 8 of observation in a single male. All other animals were without findings. No macroscopical findings were evident. The median lethal dose of erucamide after single dermal administration to rats of both sexes, observed over a period of 14 days, is: LD50 (rat): greater than 2000 mg/kg body weight