Registration Dossier

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
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.