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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
19 Jun - 05 Jul 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restriction (limited data on test material)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
no information on the analytical purity of the test substance given
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
EC Number:
234-392-1
EC Name:
Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate
Cas Number:
11138-60-6
IUPAC Name:
2,2-bis[(octanoyloxy)methyl]butyl decanoate
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: yellow liquid
- Lot/batch No.: 96012
- Expiration date of the lot/batch: 01.01.2006
- Storage condition of test material: at room temperature
- Analytical purity: neat (not further specified)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HRP, Inc., Denver, Pennsylvania
- Age at study initiation: at least 8 weeks
- Weight at study initiation: males: 2.4-3.1 kg, females: 2.5-2.7 kg
- Housing: individually in suspended, stainless steel cages with wire mesh bottoms
- Diet: Lab Rabbit Diet HF, No 5326 and No 5326, ad libitum
- Water: ad libitum
- Acclimation period: males 58 d, females 60 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 12 cm x 14 cm, clipped area of the dorsal trunk
- % coverage: approx. 10%
- Type of wrap if used: gauze secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with distilled water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; dermal examination: 1, 24, 48 and 72 h after bandage removal and on Day 8 and 15 (males) or once only on Day 8 (females); clinical signs of toxicity: 1, 2 and 4 h after dosing and daily thereafter for 14 days; body weight: Day 0, 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: food consumption: daily

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observtion period.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
None of the animal showed dermal irritation.

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