1,2,3,6-tetrahydrophthalimide

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,6-tetrahydrophthalimide

EC Number:

201-602-8

EC Name:

1,2,3,6-tetrahydrophthalimide

Cas Number:

85-40-5

Molecular formula:

C8H9NO2

IUPAC Name:

2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione

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 or test system 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