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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Justification for read-across is given in Section 13 of IUCLID.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Didodecyl fumarate
EC Number:
219-280-2
EC Name:
Didodecyl fumarate
Cas Number:
2402-58-6
Molecular formula:
C28H52O4
IUPAC Name:
didodecyl but-2-enedioate
Details on test material:
- Name of test material (as cited in study report): Didodecyl fumarate
- Physical state: solid, melt/white
- Analytical purity: 93.8 area-% (GC-FID)
- Lot/batch No.: 0008043725
- Expiration date of the lot/batch: Dec 2013
- Stability under test conditions: the stability of the test item under storage conditions over the test period was guaranteed by the sponsor.
- Storage condition of test material: RT

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks (nulliparous and non-pregnant).
- Weight at study initiation: 219 - 241 g (males), 198 - 218 g (females).
- Fasting period before study: no.
- Housing: single housing in Makrolon cage, type III.
- Diet: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany.
- Water: tap water ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 30-70 %.
- Air changes: approx. 10 per hr.
- Photoperiod: 12hrs dark / 12hrs light.

IN-LIFE DATES: from 04 to 19 Mar 2013.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: about 40 cm² clipped skin of the dorsal and dorsolateral parts of the trunk.
- % coverage: at least 10 % of the body surface.
- Type of wrap if used: the test item was covered with an air-permeable dressing (4 layers of absorbent gauze and stretch bandage).

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied: 12.50 ml/ kg.
- Concentration (if solution): 400 mg/ml.
- Constant volume or concentration used: yes
- For solids, paste formed: yes, solution was prepared and applied lukewarm.

Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: individual body weight shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes.
- Scoring of skin findings: individual readings 30 - 60 minutes after removal of the semi-occlusive dressing (day 1), several times and on the last day of observation. Scoring was performed according to Draize.

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 occurred within the study period.
Clinical signs:
No systemic clinical signs were observed during clinical examination within the study period.
Body weight:
The mean body weights of the male animals increased within the normal range throughout the study period. As generally known for females dermally applied, the weight gain only slightly increased during the first week, but increased within the normal range in the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Other findings:
Skin effect at the application site comprised very slight erythema (grade 1) in one out of five male animals and in one out of five female animals and was observed on study day 1.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No.1272/2008
Conclusions:
LD50 (rat, male/female) > 5000 mg/kg bw
Executive summary:

The acute dermal toxicity of the category substance to Wistar rats was assessed according to the OECD guideline 402. The clipped skin of dorsal and dorsolateral parts of 5 Wistar rats per sex was exposed to the test substance in corn oil at a limit dose of 5000 mg/kg bw for 24 h under semiocclusive conditions. The substance was removed after 24 hours exposure and the skin was washed. The animals were observed for 14 days for mortality and clinical signs. All the animals were also subjected to necropsy at the end of the observation period; no macroscopic pathological findings were noted. Skin effect at the application site comprised very slight erythema (grade 1) in one out of five male animals and in one out of five female animals and was observed on study day 1.

LD50 > 5000 mg/kg bw (male/female rats)