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EC number: 202-829-5 | CAS number: 100-20-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
- 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.
Reference
Hours after Initial Application |
Number of Rabbits with Skin Corrosion |
4 |
0/6 |
24 |
0/5 |
48 |
0/5 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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.
- 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.
Reference
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 |
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.
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