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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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

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.