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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 12 March 1992 to 28 April 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non-GLP guideline study with deviations: only one animal tested (absence of skin irritation potential not confirmed with additional animals), and the same animal was used 7 days later for the ocular irritation test. The study report contains only limited descriptions on study design, housing conditions and results.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
described in the directive 84/449/CEE
Deviations:
yes
Remarks:
only one animal tested, and the same animal was tested 7 days later for ocular irritation
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl diethoxyacetate
EC Number:
227-999-8
EC Name:
Ethyl diethoxyacetate
Cas Number:
6065-82-3
Molecular formula:
C8H16O4
IUPAC Name:
ethyl 2,2-diethoxy-acetate
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole of Val de Selle
- Age at study initiation: no data
- Weight at study initiation: 3.2 kg
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data

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

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: nothing reported in the study report. Assumed to be an untreated area of the rabbit skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL unchanged
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
1 hour, 24, 48 and 72 hours after the dressing removal
Number of animals:
1 female
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
- Mode of administration: 0.5 mL of the test material was applied to the anterior flank of the female rabbit for 3 minutes. The posterior flank of the same animal received 0.5 mL of the test material for 4 hours.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: no data (assumed to be that described in directive 84/449/CEE)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
only one animal treated
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: 4-h application ; no other cutaneaous reaction after 24, 48 or 72h
Irritation parameter:
other: cutaneous reaction
Basis:
animal #1
Remarks:
only one animal treated
Time point:
other: 1 h
Remarks on result:
no indication of irritation
Remarks:
no cutaneaous reaction observed
Irritation parameter:
other: cutaneous reaction
Basis:
animal #1
Remarks:
only one animal treated
Time point:
24 h
Remarks on result:
no indication of irritation
Remarks:
no cutaneous reaction observed
Irritation parameter:
other: cutaneaous reaction
Basis:
animal #1
Remarks:
only one animal treated
Time point:
48 h
Remarks on result:
no indication of irritation
Remarks:
no cutaneous reaction observed
Irritation parameter:
other: cutaneous reaction
Basis:
animal #1
Remarks:
only one animal treated
Time point:
72 h
Remarks on result:
no indication of irritation
Remarks:
no cutaneous reaction observed
Irritant / corrosive response data:
No skin reaction was observed following the 3 minutes application of the test material.
Only a slight erythema (score of 1) was observed at the 1 hour observation time point. No skin reactions were noted thereafter.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: based on the observed data
Conclusions:
Under the experimental conditions of this test, the test material was considered non irritant to the rabbit skin following 4 hours of exposure.
Executive summary:

This non-GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to the EU method B4 described in annex V of the 84/449/CEE directive.

 

Material and methods

0.5 mL of the test material were applied as supplied to the anterior flank of one female rabbit for 3 minutes. The posterior flank of the same animal received 0.5 mL of the test material for 4 hours.

The skin reactions were recorded 1 hour, 24, 48 and 72 hours after the dressing removal.

 

Results

No skin reaction was observed following the 3 minutes application of the test material.

Only a slight erythema (score of 1) was observed at the 1 hour observation time point. No skin reactions were noted thereafter. 

 

Conclusion

Under the experimental conditions of this test, the test material was considered non-irritant to the rabbit skin following 4 hours of exposure.