Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name as cited in report: Adipic acid, cyclic ester with diethyleneglycol
- Analytical purity: ca. 90%
- Physical state: Solid/white crystals
- Storage: refrigerated
- Lot/batch No.: B 74

Test animals

Species:
rabbit
Strain:
other: New Zealand White/Chbb: NZW (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Sex: Male (2), female (1)
- Age at study initiation: young adults
- Weight at study initiation: 3.79 kg - 3.87 kg
- Housing: singly
- Diet: ad libitum, Kliba Labordiaet (the feed was assayed for chemical and microbiological contaminants)
- Water: ad libitum, tap water (drinking water is regularly assayed for chemical and microbilogical contaminants)
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1 h, 24 h, 48 h and 72 h after removal of the patch
Number of animals:
3
Details on study design:
At least 24 hours before the test, the fur was removed by clipping the dorsal part of the trunk (upper third of the back or flanks) of the animals. The test patch (2 .5 cm x 2 .5 cm), which had been moistened with aqua bidest was covered with a dose of the unchanged solid test substance. The test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressing. The skin of the animals was washed at the end of the exposure time with Lutrol(R) and Lutrol(R)/water (1 :1). Body weights of the test animals were determined shortly before the application of the test substance. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Reading and scoring of the skin changes was performed 1 h, 24 h, 48 h and 72 h after removal of the patch. Scoring system used was the OECD Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h, 48h, 72h
Score:
0
Remarks on result:
other: Slight erythema (score of 1 in each animal) was observed in all animals 1 h after application. However, effects were reversible in all animals within 24 hours after removal of the patch i.e. at the 24h reading.
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h, 48h, 72h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information