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EC number: 203-187-9 | CAS number: 104-23-4
- 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
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- 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
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- 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
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- Endpoint summary
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- 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
Skin irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the dermal irritation potential of the test chemical. Based on the summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the testchemical is unable to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Eye irritation
The ocular irritation potential of target chemical was assessedin various experimental studies which were conducted on rabbit for test chemicaland its structurally similar read across substances.. Based on the summarized studies for test chemical and its structurally and functionally similar read across substances, it can be concluded that the test chemical is unable to cause eye irritation and thus considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of test substances
- Justification for type of information:
- Data for the target chemical is summarized based on the available studies
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on skin irritation studies as- WoE-2, WoE-3 and WoE-4.
The eye irritation studies were condcuted on rabbits to assess its skin irritating effects. - GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: 1. and 2.New Zealand White 3.HC:NZW
- Details on test animals or test system and environmental conditions:
- 1.Details on test animals
Age: 10 to 12 weeks
Sex:Female
Body weight range: 2.0kg±200g
Identification : By cage tag and corresponding colour body marking
Housing:Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet:Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
Water:Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
Acclimatization: The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
Randomization: After acclimatization and Veterinary examination three females were randomly selected.
Details on environmental conditions:
- Temperature (°C): temperature between 22-25 deg C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): Air conditioned rooms with 10-15 air changes per hour,
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
HUSBANDRY
Environmental conditions :Air conditioned rooms with 10-15 air changes per hour, temperature between 19-25 0C, relative humidity 30-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles,mad-libitum
2.TEST ANIMALS
- Weight at study initiation: 3 – 4 kg
3.- Sex: Female
- Age at study initiation: adult
- Weight at study initiation: 3.2-3.3 kg - Type of coverage:
- other: 1.occlusive 2.not specified 3.semiocclusive
- Preparation of test site:
- other: 1.clipped 2.not specified 3.Mechanically depilated skin of flanks
- Vehicle:
- other: 1 and 2.unchanged (no vehicle) 3.water
- Controls:
- not specified
- Amount / concentration applied:
- 1.500 mg (0.5g)
2.500 mg
3.500 mg - Duration of treatment / exposure:
- 1.4 hours
2.24 hours
3.4 hrs - Observation period:
- 1.60 min., 24, 48 and 72 hours after application.
2.7 days
3.1,24,48 and 72 hrs and day 7 - Number of animals:
- 1.3 female rabbits
2. 2 rabbits
3.3 female rabbits - Details on study design:
- 1.TEST SITE
- Area of exposure: dorsal area of trunk
- % coverage: small area (approximately 6 cm2)
- Type of wrap if used: impervious dressing which was secured in position with adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure:after patch removal the test site was washed with lukewarm water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application.
SCORING SYSTEM:
- Method of calculation:The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method
2.TEST SITE
Area of exposure: Inner surface of ears
% coverage: Not mentioned
Type of wrap if used: Under an adhesive dressing
REMOVAL OF TEST SUBSTANCE
Washing (if done): The test substance was washed off with water and soap/vegetable oil.
Time after start of exposure: After the exposure period
SCORING SYSTEM: Not mentioned
3.SCORING SYSTEM: Draize method. - Irritation parameter:
- other: 1.primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: 2.overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: 3.erythema and edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1.The test compound applied at the dose level of 500mg on shaven back skin of rabbit did not produced any irritation to skin during period of observation.
2.No skin irritation was observed.
3.None of the test animals produced skin reactions. - Other effects:
- 1.The test compound applied at the dose level of 500mg on shaven back skin of rabbit did not produced any irritation to skin during period of observation.
2.No skin irritation was observed.
3.None of the test animals produced skin reactions. - Interpretation of results:
- other: Not irritating
- Conclusions:
- The test chemical was considered to be not irritating to the skin of rabbits.
- Executive summary:
Various studies were performed on rabbits to assess the dermal irritation potential of test chemical which have been summarized as follows:
A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of Test chemical. Three female New Zealand White rabbits. The animals were prepared 24 hours prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 500gm (0.5g) of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application and the responses were scored according to Draize method. The Primary Irritation Index (PII) for Test chemical after 14 days of observation was 0.0.AlsoTest chemical did not produce pain and any clinical signs of toxicity throughout the examination period of 14 days. Hence, under the test conditions, the Test chemical can be concluded to be not irritating to New Zealand White rabbit skin.
In next skin irritation study, approx. 500 mg of test chemical was applied to the inner surface of the ears of 2 rabbits. Male and Female New Zealand white rabbits were used for the study. The test chemical was applied under an adhesive dressing for 24 hours. At the end of the exposure period, the test substance was washed off with water and soap/vegetable oil. The observation period was 7 days. No skin irritation was observed after 7 days. Thus on the basis of the above study, the test substance, 7-amino-4-hydroxy-2-naphthalenesulfonic acid can be considered non-irritant to rabbit skin.
The above results were further supported by the Primary Skin irritation study conducted for test chemical to determine its skin irritating behavior in accordance with OECD guideline No. 404. The animals were subjected to a single 4- hour exposure to 500 mg of the test substance, mixed into a paste with water and applied semi-occlusively to the mechanically depilated skin of the flanks. The findings were scored after 1, 24, 48 and 72 hours as well as 7 days in accordance with the Draize method. The average irritation scores according to the Draize scoring for erythema and oedema were 0.0. Hence, the test chemical was considered to be not irritating to skin of female albino rabbits.
All these studies lead to a conclusion that Test chemical is indeed not irritating to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.
Reference
1.
TABLE - 1
INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES
Rabbit No. |
Sex |
INTACT SKIN |
|||||||||||
3 Min. |
4 Hours |
24 Hours |
48 Hours |
72 Hours |
14 days |
||||||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
||
01 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
F |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
F |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Grand Total |
0.00 |
Dermal Irritation Index: 0.0/4 = 0.0
2.Not specified
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of test substances
- Justification for type of information:
- Data for the target chemical is summarized based on the available studies
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- WoE report is based on eye irritation studies as- WoE-2, WoE-3 and WoE-4.
An eye irritation studies were condcuted on rabbits to assess its ocular effects. - GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: 1. and 2.New Zealand White 2.not specified
- Details on test animals or tissues and environmental conditions:
- 1.Details on test animals:
- Age: 10 to 12 weeks
- Sex: Female
- Body weight range: 2.0kg ±200g
- Housing: Rabbit was housed in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
- Diet:Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
- Water:Community tap water passed through ‘Aqua Guard on line water filter’ was kept in bottles, ad libitum.
- Acclimatization: The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
ENVIRONMENTAL CONDITIONS
- Temperature:temperature between 22-250C
- Humidity (%):relative humidity 40-60%
- Air changes (per hr):Air conditioned room with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
HUSBANDRY
Environmental conditions :Air conditioned rooms with 10-15 air changes per hour, temperature between 19-25 0C, relative humidity 30-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi, India
Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles,mad-libitum
2. Not specified
3.No data available - Vehicle:
- other: 1 and 2.unchanged (no vehicle) 3.water
- Controls:
- yes
- Amount / concentration applied:
- 1.100mg (0.1g)
2.50 mg
3.100 µl - Duration of treatment / exposure:
- 1.24 hours
2.24 hours
3.3 days - Observation period (in vivo):
- 1.The eyes were examined at 1, 24, 48 and 72 hours after test substance application
2.7 days
3.3 days - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1.3 female rabbits
2.2 rabbits
3.6 rabbits - Details on study design:
- 1.REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein.
2.TEST SITE
Area of exposure: conjunctival sac
% coverage: no data
Type of wrap if used: no data
3.TEST SITE
- Area of exposure: the conjunctival sac of eye
- % coverage: No data
- Type of wrap if used: No data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
SCORING SYSTEM: No data - Irritation parameter:
- other: 1.overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: 2.overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: 3.overall irritation score
- Basis:
- mean
- Time point:
- other: 3 days
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1.The test compound when applied to the eye of New Zealand white rabbit at the dose level of 0.1gm did not produce any lesions such as pannus, staining throughout the observation period of 72 hours.
2.No eye irritation was observed.
3.Slight reddening in only one of 6 animals was observed but this was reversible after 3 days. - Other effects:
- 1.The test compound applied in conjunctival sac of rabbits did not show any observable clinical signs of eye irritation throughout the observation period of 21 days.
2.No eye irritation was observed.
3.Slight reddening in only one of 6 animals was observed but this was reversible after 3 days. - Interpretation of results:
- other: not irritating
- Conclusions:
- The Test chemical was considered to be not irritating to the eyes of treated rabbits.
- Executive summary:
Various studies were performed on rabbits to assess the ocular irritation potential of test chemical which have been summarized as follows:
An ocular irritation study was conducted on New Zealand white rabbits in accordance with OECD 405 to assess the irritation parameter of Test chemical. Three female New Zealand White rabbits were used for the study. 0.1g of the undiluted test chemical was instilled in the conjunctival sac of rabbits after gently pulling the lower lid away from the eyeball. The other eye which remained untreated served as a control. The ocular lesions were evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reactions (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weights before and during the study was observed. The overall irritation index of Test chemical was 0.0 after 72 hours. Also Test chemical did not produce any clinical signs of toxicity throughout the examination period of 21 days. Hence, under the test conditions, the Test chemical can be concluded to be not irritating to New Zealand White rabbit eyes. The results obtained from these studies lead to a conclusion that Test chemical is indeed not irritating to eye. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.
In next eye irritation study in rabbits, 50 mg of test chemical was instilled into the conjunctival sac of 2 animals. New Zealand white rabbits were used for the study. The animals were observed for 7 days. No eye irritation was observed after 7 days. Hence, the test chemical can be considered non-irritant to rabbit eyes.
The above results were further supported by the Eye irritation study conducted in 6 rabbits for test chemical to assess its eye irritation efficacy in accordance with OECD guideline 405. About 100 μl of chemical was placed into the conjunctival sac of each rabbits and the results were recorded for 3 days. Slight reddening in only one of 6 animals was observed but this was reversible after 3 days. Since the observed eye effects were not persisted after 3 days, the test chemical was considered to be not irritating to rabbits’ eye.
The results obtained from these studies lead to a conclusion that Test chemical is indeed not irritating to eye. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.
Reference
1.
TABLE- 1 GRADING OF OCULAR LESIONS
S.NO/ SEX |
|
OBSERVATION |
Score |
Total |
Total Score |
|||
1/F
|
1 hr |
24hrs |
48 hrs |
72 hrs |
||||
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
|
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
0+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
2/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
0+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
3/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
1 |
0+0+0×5=5 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
0 |
0 |
0 |
0 |
|||
Grand total |
0.00 |
|||||||
Mean |
0.00 |
|||||||
Eye Irritation Scoring index |
0.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin irritation potential of the test chemical. The studies are as mentioned below:
A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of Test chemical. Three female New Zealand White rabbits. The animals were prepared 24 hours prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 500gm (0.5g) of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application and the responses were scored according to Draize method. The Primary Irritation Index (PII) for Test chemical after 14 days of observation was 0.0.AlsoTest chemical did not produce pain and any clinical signs of toxicity throughout the examination period of 14 days. Hence, under the test conditions, the Test chemical can be concluded to be not irritating to New Zealand White rabbit skin.
In next skin irritation study, approx. 500 mg of test chemical was applied to the inner surface of the ears of 2 rabbits. Male and Female New Zealand white rabbits were used for the study. The test chemical was applied under an adhesive dressing for 24 hours. At the end of the exposure period, the test substance was washed off with water and soap/vegetable oil. The observation period was 7 days. No skin irritation was observed after 7 days. Thus on the basis of the above study, the test substance, 7-amino-4-hydroxy-2-naphthalenesulfonic acid can be considered non-irritant to rabbit skin.
The above results were further supported by the Primary Skin irritation study conducted for test chemical to determine its skin irritating behavior in accordance with OECD guideline No. 404. The animals were subjected to a single 4- hour exposure to 500 mg of the test substance, mixed into a paste with water and applied semi-occlusively to the mechanically depilated skin of the flanks. The findings were scored after 1, 24, 48 and 72 hours as well as 7 days in accordance with the Draize method. The average irritation scores according to the Draize scoring for erythema and oedema were 0.0. Hence, the test chemical was considered to be not irritating to skin of female albino rabbits.
Based on the above summarized studies for test chemical and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause skin irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Eye irritation
Various studieshas been investigated for the test chemical to observe the potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for test chemicaland its structurally similar read across substanceswhich have beensummarized as below;
An ocular irritation study was conducted on New Zealand white rabbits in accordance with OECD 405 to assess the irritation parameter of Test chemical. Three female New Zealand White rabbits were used for the study. 0.1g of the undiluted test chemical was instilled in the conjunctival sac of rabbits after gently pulling the lower lid away from the eyeball. The other eye which remained untreated served as a control. The ocular lesions were evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reactions (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weights before and during the study was observed. The overall irritation index of Test chemical was 0.0 after 72 hours. Also Test chemical did not produce any clinical signs of toxicity throughout the examination period of 21 days. Hence, under the test conditions, the Test chemical can be concluded to be not irritating to New Zealand White rabbit eyes. The results obtained from these studies lead to a conclusion that test chemical is indeed not irritating to eye.
In next eye irritation study in rabbits, 50 mg of test chemical was instilled into the conjunctival sac of 2 animals. New Zealand white rabbits were used for the study. The animals were observed for 7 days. No eye irritation was observed after 7 days. Hence, the test chemical can be considered non-irritant to rabbit eyes.
The above results were further supported by the Eye irritation study conducted in 6 rabbits for test chemical to assess its eye irritation efficacy in accordance with OECD guideline 405. About 100 μl of chemical was placed into the conjunctival sac of each rabbits and the results were recorded for 3 days. Slight reddening in only one of 6 animals was observed but this was reversible after 3 days. Since the observed eye effects were not persisted after 3 days, the test chemical was considered to be not irritating to rabbits’ eye.
Based on the above summarized studies for test chemical and its structurally similar read across substances,it can be concluded that the testchemical is not able to cause eye irritation and considered as not irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical and its structurally and functionally similar read across substanceswere observed in various studies. The results obtained from these studies indicate that the chemical is unable to cause skin and eye irritation. Hence test chemical can be classified under the category “Not Classified” for skin and eye as per CLP.
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