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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:
08 - 29 Dec 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

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)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Erucamide
- Physical state: white solid
- Storage condition of test material: room temperature, protected from direct sunlight
- Expiration date of the lot/batch: 2 Jul 2011
- Stability under test conditions: stable
- Analytical purity: 99.2%
- Lot/batch No.: 0821205214

Test animals

Species:
rat
Strain:
other: RccHan:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., NM Horst, Netherlands
- Age at study initiation: 8 weeks (males), 12 weeks (females)
- Weight at study initiation: 238 – 250 (males), 196 – 210 (females)
- Housing: Animals were housed in groups of 5 of the same sex in Makrolon® type-4 cages (during acclimatization) and individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel" J. Rettenmaier & Söhne GmbH & Co KG, Rosenberg, Germany)
- Diet: Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: six days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze pad was 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

REMOVAL OF TEST SUBSTANCE
- Washing: The dressing was removed and the skin was flushed with lukewarm tap water and drapped off with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 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: Animals were observed 30 min, 1, 2, 3, and 5 h post administration of the test substance and twice daily thereafter for 14 days. Individual body weights were determined weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were observed 30 min, 1, 2, 3, and 5 h post administration of the test substance and once daily thereafter for 14 days.
Statistics:
Not applicable

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: no mortalities or clinical signs of toxicity observed
Mortality:
No deaths occurred during the study period.
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 during the study period.
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

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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