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Description of key information

Dermal, rabbit: not corrosive, Reliability = 2

Eye, rabbit: not irritating [CAS# 100-21-0], Reliability = 2

While the material is not classified as a corrosive based on experimental data provided, it is known that an association with water produces the products of hydrolysis (organic acid and HCl) which would be expected to be corrosive to the skin and eye. The submitter acknowledges that in reality, exposure to human skin and eyes would include moisture, leading to a corrosive condition with sufficient exposure time and is classified as Cat 1A for skin corrosion and Cat 1 for eye damage.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Similar to, but not conducted under current guideline skin corrosion test methodology.
Qualifier:
according to guideline
Guideline:
other: Skin Corrosion Test as defined in Department of Transportation Hazardous Materials Regulations, Title 49 CFR, Section 173.240(a)(1), December 31, 1973.
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Albino rabbits
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2-3 kg
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
Observations done at 4, 24 and 48 hours.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Back
- % coverage: 1.5 by 1.5 inch coverage
- Type of wrap if used: 12 ply cotton gauze pads then trunk of animal loosely wrapped with rubber sheeting.

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

SCORING SYSTEM: Not reported

Skin reactions were evaluated after removal of the wrapping. Readings were again made at 24 and 48 hours after the initial application.
Irritation parameter:
other: corrosion
Basis:
animal: 1 - 5
Time point:
other: 4, 24, 48 hours
Remarks on result:
other: no skin corrosion
Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
24 h
Remarks on result:
other: no skin corrosion
Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
48 h
Remarks on result:
other: no skin corrosion
Irritation parameter:
erythema score
Basis:
animal: 1-5
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
24 h
Remarks on result:
other: no skin corrosion
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
48 h
Remarks on result:
other: no skin corrosion
Irritation parameter:
edema score
Basis:
animal: 1-5
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
No skin corrosion in any of the rabbits.
Other effects:
One rabbit died prior to 24-hour reading from non-compound related cause.

Hours after Initial Application

Number of Rabbits with Skin Corrosion

4

0/6

24

0/5

48

0/5

Interpretation of results:
GHS criteria not met
Conclusions:
Not corrosive to skin.
Executive summary:

0.5 gm of the test substance was applied to a 1.5 by 1.5 inch area of the clipped dorsal skin of six albino rabbits. The treated area was covered with an occlusive dressing. After 4 hours, the wrapping was removed any skin reactions evaluated. The test sites were then washed. Readings were again made at 24 and 48 hours after the initial application. There was no skin corrosion. One rabbit died prior to the 24-hour reading from non-compound related cause. According to the Regulations of the Department of Transportation, the test substance is not corrosive to skin.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
This study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions). The study, if used in support of terephthalic acid, has a reliability of 1 (reliable without restriction).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Albino rabbits
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg undiluted test substance
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
Observations were made at 1, 24, 48 and 72 hours, and 7 days post application.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
6
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: not reported
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
10
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
5
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All irritant effects had disappeared by the 48 hour observation. One rabbit was assigned a score of 10 for corneal irritation at the 24 hour time point, but returned to normal by the 48 hour observation. No other corneal effects were observed. Individual animal data are presented in Table 1. The average irritation score 1 hour after application was 9.0 (out of a possible 110), and at 24 hours was 4.5 (out of a possible 110).
Other effects:
not reported.

Table 1. Individual rabbit data showing eye irritation scores. The scores given at the 48 and 72 hour and 7 day time points were the same, hence these scores have been given in one column.

Tissue

Rabbit No.

1 hour

24 hours

48 hours, 72 hours, 7 days

Cornea

1

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

2

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

3

0

10

0

Iris

5

5

0

Conjunctiva

4

6

0

Total

9

21

0

 

Cornea

4

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

5

0

0

0

Iris

5

0

0

Conjunctiva

4

2

0

Total

9

2

0

 

Cornea

6

0

0

0

Iris

5

0

0

Conjunctiva

4

4

0

Total

9

4

0

 

Averages

 

 

 

 

Cornea

0.0

1.7

0

Iris

5.0

0.8

0

Conjunctiva

4.0

2.0

0

Total

9.0

4.5

0

 

Interpretation of results:
GHS criteria not met
Conclusions:
The author classified the test substance not irritating to the eyes of rabbits
Executive summary:

Limited information is available regarding this study. 100 mg undiluted test substance was applied to the eyes of albino rabbits. One rabbit showed a stronger reaction than the others, but in all cases eyes had returned to normal within 48 hours. The average irritation score 1 hour after application was 9.0 (out of 110), and at 24 hours was 4.5 (out of 110). The author classified the test substance as non-irritating to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The substance was applied to the dorsal skin of albino rabbits at a dose level of 0.5 g. The treated area was covered with an occlusive dressing. After 4 hours, the wrapping was removed any skin reactions evaluated. The test sites were then washed. Readings were again made at 24 and 48 hours after the initial application. There was no skin corrosion. One rabbit died prior to the 24-hour reading from non-compound related cause. The Authors indicated the test substance is not corrosive to skin.

 

Eye

The substance rapidly hydrolyses to terephthalic acid (TPA). Therefore, the eye irritation study for TPA is being used to support meeting this data requirement. The eye irritation test was conducted on 6 albino rabbits. 100 mg undiluted test substance was applied to the eyes of the rabbits. The test substance was not washed from the eyes. Observations were made at 1, 24, 48 and 72 hours, and 7 days post application. One rabbit showed a stronger reaction than the others, but in all cases eyes had returned to normal within 48 hours. The average irritation score 1 hour after application was 9.0 (out of 110), and at 24 hours was 4.5 (out of 110). The author classified the test substance as non-irritating to rabbit eyes.

Justification for classification or non-classification

Data on the parent chemical itself has been shown to not be an irritant or corrosive in experimental animal studies. While the material is not classified as a corrosive based on experimental data provided, it is known that an association with water produces the products of hydrolysis (organic acid and HCl) which would be expected to be corrosive to the skin and eye. The submitter acknowledges that in reality, exposure to human skin and eyes would include moisture, leading to a corrosive condition with sufficient exposure time. Therefore, the chemical warrants classification as Cat 1A (H314: Causes severe skin burns and eye damage) for skin irritation and Cat 1 (H318: Causes serious eye damage) for eye irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.