Registration Dossier

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:
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 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:
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.