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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
January 09 to March 02, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
This IUCLID for dimethyl adipate is compiled using data from the substance itself, a structuraly related compound (dimethyl glutarate) and a mixture of dibasic esters (dimethyl adipate, succinate and glutarate). The toxicity of each of these susbtances is similar and the document attached justifies why data on the category members can be used to support the data gaps for dimethyl adipate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
See the information in the field "Confidential detail on test material"

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: L'Abbaye de Bellefontaine, F-49122 Begrolles en Mauges, France
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3 °C
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1h, 24h, 48 h, and 72 h after exposure termination;
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: right flank
- coverage: 6 cm²
- Type of wrap if used: gauze patch held in place with semi-occlusive dressing

SCORING SYSTEM:
Erythema score: 0-4
Edema score: 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Under the conditions of this assay, the test article has no skin irritating potential.
Executive summary:

DBE has been tested for skin irritation on 3 New Zealand White rabbits according to OECD guideline n° 404 and EU guideline n° B.4 (Draize Method) in compliance with Good Laboratory Practice. The rabbits received a dermal dose of 0.5 ml of DBE on a gauze on intact and abraded skin sites under an semiocclusive dressing for a period of 24 hours. Scores for erythema and oedema were measured 1, 24, 48 and 72 hours after patch removal and primary cutaneous index was calculated (maximum possible index =12). No sign of dermal irritation (score = 0 for erythema and oedema) was observed for intact skin site of the 3 rabbits at any reading time. Primary Irritation Index was = 0.0. No other signs of intoxication were observed.

Based on these results DBE is not classified irritating to skin according to the criteria of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).