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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S. Association of Food and Drug Officials (AFDO)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10
Type of coverage:
semiocclusive
Preparation of test site:
other: Both flanks were shaved. One flank was left shaved, the other was additionally abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g applied on a patch of 2.5x2.5 cm2
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm2
- Type of wrap if used: impermeable material

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize score for erythema, edema
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.1
Max. score:
3
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1.45
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: intact skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.8
Max. score:
2
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: intact skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: intact skin
Interpretation of results:
slightly irritating
Remarks:
Migrated information not requiring classification Criteria used for interpretation of results: EU
Conclusions:
The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.
Executive summary:

The test material applied to the skin is slightly irritant. Irritation disappears until 72 hours.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed before GLP guidelines and OECD guidelines were in place for industrial chemicals. The study has been performed in a lab experienced to work under GLP for pharmaceuticals. The test method is similar to the later used OECD guideline method.
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) by the U.S.
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2.0 kg
- Housing: individual metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minumum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): 55 +/-5
- Photoperiod (hrs dark / hrs light): 14 / 10
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
In half of the animals the treatment lasted for 30 seconds (time of flushing with water)
In half of the animals the treatment was not stopped.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in half of the animals the eye was flushed with 10 ml lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours, unrinsed
Score:
ca. 13
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: maximum possible score is 80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours, unrinsed
Score:
ca. 13
Max. score:
20
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours, unrinsed
Score:
ca. 10
Max. score:
20
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 96 hours, unrinsed
Score:
ca. 7
Max. score:
15
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days, unrinsed
Score:
ca. 3.3
Max. score:
5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours - 7 days, unrinsed
Score:
0
Max. score:
0
Reversibility:
other: no effect
Remarks on result:
other: maximum possible score is 10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours, unrinsed
Score:
ca. 15
Max. score:
16
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: maximum possible score is 20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours, unrinsed
Score:
ca. 14
Max. score:
16
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours, unrinsed
Score:
ca. 11
Max. score:
14
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 96 hours, unrinsed
Score:
ca. 7
Max. score:
12
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days, unrinsed
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Interpretation of results:
Category 2B (mildly irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The effects are mild, however cornea effects are not fully reversible within 7 days.
Executive summary:

The effects are mild, however cornea effects are not fully reversible within 7 days.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

The substance as described in Section 1.2 contains approx. 30% of benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA), CAS 552-30-7 / EC 209-008-0.

TMA is classified with Eye Damage 1, H318 and with STOT SE 3, H335 for irritating effects on the respiratory tract . Therefore this substance is also classified for Eye Damage 1, H318 and STOT SE 3, H335.

The classification for eye irritation is supported by the available study for this substance.