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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
March 12th, 1985 - March 26th, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 79/831/EWG, Annex V, Part B
Deviations:
yes
Remarks:
analytical purity of test substance not given
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C16-18 and C18-hydroxy mono- and di-
EC Number:
295-191-2
EC Name:
Glycerides, C16-18 and C18-hydroxy mono- and di-
Cas Number:
91845-19-1
IUPAC Name:
91845-19-1
Details on test material:
- Name of test material (as cited in study report): Glycerides, C16-18 and C18-hydroxy mono- and di-
- Batch No.: 4026-3
- Physical state: pellets
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: average weights: males: 179 g, females: 143
- Fasting period before study: no data
- Housing: individually in Makrolon cages type II with soft wood bedding
- Diet (e.g. ad libitum): Altromin 1324, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 51
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 12th, 1985 - March 26th, 1985

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsum
- % coverage: 6 cm x 4 cm
- Type of wrap if used: gauze, polyethylen foil, leukosilk bandage and acrylastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
Duration of exposure:
24 hours
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: several times on day of application, thereafter twice a day
- Frequency of observations and weighing: before administration and on days 2, 7 and 14.
- Necropsy of survivors performed: yes, after 14 days from all treated animals
- Other examinations performed: daily skin examination

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: rat
Mortality:
None.
Clinical signs:
other: No signs of systemic toxicity were observed.
Gross pathology:
No abnormalities observed.
Other findings:
No local skin irritation observed.

Applicant's summary and conclusion

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