1,2,3,6-tetrahydrophthalic anhydride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to recognised OECD test methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrophthalic anhydride

EC Number:

247-570-9

EC Name:

Tetrahydrophthalic anhydride

Cas Number:

26266-63-7

IUPAC Name:

3a,4,7,7a-tetrahydro-2-benzofuran-1,3-dione

Details on test material:

- Name of test material (as cited in study report): Tetrahydrophthalsäureanhydrid (THPSA)
- Physical state: Solid
- Analytical purity: >99.0%
- Lot/batch No.: Verformung der Nachtschicht vom 02./03.03.1988
- Storage condition of test material: Protected from light and humidity

Test animals

Species:

rabbit

Strain:

other: weisse russen

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 1.9 - 2.1 kg
- Housing:
- Diet (e.g. ad libitum): K4 rabbit diet from Ssniff Spezialfutter GmbH, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 55 - 65 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 1988-05-27 To: 1988-06-02

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): Water used as binding agent
:

Duration of treatment / exposure:

4 hours

Observation period:

6 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 (2.5 x 2.5 cm)
- Type of wrap if used: Elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale as described in OECD test guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24-72 hours

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 - 72 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24 - 72 hours

Score:

0

Max. score:

0

Any other information on results incl. tables

Animal	1 hour		24 hours		48 hours		72 hours		6 days
number	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1	1	0	1	0	1	0	0	0	0	0
2	1	0	1	0	0	0	0	0	0	0
3	1	0	1	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Tetrahydrophthalic anhydride is not irritating to the skin

Executive summary:

Acute dermal irritation has been investigated in the rabbit according to OECD test methods. The substance was not irritating to the skin following 4 hours exposure.