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Diss Factsheets

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:
01 Jul 1992 - 31 Jul 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
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

Constituent 1
Chemical structure
Reference substance name:
Dodecanoic acid, ester with 1,2-propanediol
EC Number:
253-462-2
EC Name:
Dodecanoic acid, ester with 1,2-propanediol
Cas Number:
37321-62-3
Molecular formula:
C15H30O3 C27H52O4
IUPAC Name:
37321-62-3

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Bor: WISW (SPF Cpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not stated
- Weight at study initiation: 200-300 g
- Fasting period before study: no
- Housing: individual in Makrolon Type III cages
- Diet (ad libitum): Ssniff R10, Soest, Germany, commercial feed for rats.
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- 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: dorsal area, clipped skin area
- % coverage: 10% of body surface
- Type of wrap if used: gauze, acrylastic bandage, plaster stripes for fixation

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.17 ml/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes


Duration of exposure:
24h
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
- Necropsy of survivors performed: yes
- Clinical signs: at 0.5, 1, 2, 3, 4, 5, 6h after application and once daily thereafter. Skin appearance was recorded individually.
- Body weight: Day 0 (treatment), Day 7 and Day 14

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortalities.
Clinical signs:
other: No abnormal signs. No abnormal skin appearance.
Body weight:
other body weight observations
Remarks:
no effect on body weight was noted.
Gross pathology:
No macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.