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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "Diäthylcarbonat"
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Lot/batch No.: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: hair cut with electric hair cutter and not scarified/scarified with scarificator
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 microliter
Duration of treatment / exposure:
24 h
Observation period:
8 d; times of observation, after start of application of test substance: 24 h (detailed: 24.5 h), 48 h (data not reported), 72 h, 8d
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
0.3
Reversibility:
other: no erythema at all; yes for edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: until 72 h
Remarks on result:
other: single scores: 0, 1, 1, 1, 1, 2; not scarified
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: until 72 h
Remarks on result:
other: single scores: 0, 0, 0, 1, 0, 0; scarified

Any other information on results incl. tables

8 d value with no valuation for irritation index as value was “0” for all six animals, scarified and non-scarified areas.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: conclusion in study report
Conclusions:
The test substance diethyl carbonate was not irritating to rabbit skin.