Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P2008
- Analytical purity: 97.7%
- Impurities (identity and concentrations): Tetrahydrophthalic anhydride D3 - 0.02%; Tetrahydrophthalic anhydride D4 - 0.05%;
Tetrahydrophthalimide D3 - 1.48%; Tetrahydrophthalimide D4 isomer - 0.75%
- Lot/batch No.: 1801

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Limited, Moston, Sandbach, Cheshire, England
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.46 - 2.80 kg
- Housing: Individually housed in metal cages
- Diet (e.g. ad libitum): Conventional labroatory diet (Spillers Rabbit Diet, Dalgety Agriculture Limited, Bristol, England) available ad libitum
- Water (e.g. ad libitum): Municipal supply drinking water available ad libitum
- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 49 - 61
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark


IN-LIFE DATES: From: 1991-01-09 To: 1991-01-12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped free of fur
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Gauze patch secured in place with "Blenderm" surgical adhesive tape. Overlaid by "Tubigrip" elasticated bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed by swabbing skin with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize scale (See Table 1)

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-72 hours
Score:
<= 0.1
Max. score:
8
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Slight erythema observed in 2 of 3 animals 1 hour after the 4 hour dosing period.
Reaction remained in 1 animal at 24 hours.
Complete recovery occurred within 48 hours

Method of calculating maximum irritation score: Maximum score for erythema (4) + maximum score for oedema (4) at each of the 3 time points (24, 48 and 72 hour examinations) and each animal divided by number of animals (3) and number of examinations (3)

Any other information on results incl. tables

Table 2: Irritation: Individual findings

Animal

number

Time of

examination

Erythema

Oedema

1 Hour

1

0

15

24 Hours

1

0

48 Hours

0

0

_

72 Hours

0

0

1 Hour

1

0

36

24 Hours

0

0

48 Hours

0

0

_

72 Hours

0

0

1 Hour

0

0

67

24 Hours

0

0

48 Hours

0

0

_

72 Hours

0

0

Applicant's summary and conclusion

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