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EC number: 203-973-1 | CAS number: 112-45-8
- 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
Skin Irritation:
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404. A volume of 0.5 ml of test item (as such) was applied to the skin for 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method. The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.
Eye Irritation:
Acute Eye Irritation/Corrosion Study of Test chemical in Rabbits, was performed as per OECD guideline No. 405. The. 0.1 ml of test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions. The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes. 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin in rabbits
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Procured from LIVEON BIOLABS PVT. LTD., Karnataka, 572106, (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
- Sex: Male
- Health Status: Healthy young adults rabbits were used for the study.
- Age at study initiation: 4.0 to 4.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.888 kg and Maximum: 2.612
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No. 200004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item
- Identification : During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed minimum twice a week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.90 °C and Maximum: 22.50 °C
- Humidity (%): Minimum: 51.50 % and Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable - Duration of treatment / exposure:
- 4-hour exposure period
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr
Control site: 0.5 ml distilled water was applied at control site. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
Body weights were increased as compared to day 0 in all the three animals - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.
Hence, it was concluded that the test chemical was Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested. - Executive summary:
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with cotton soaked in distilled water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.
At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.
Reference
Table 1: Skin Reaction
In Treated area Dose:0.5 ml of test item Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Right |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
2 |
Confirmatory |
Left |
1 |
2 |
2 |
2 |
0 |
1 |
1 |
2 |
1 |
0 |
3 |
Left |
1 |
2 |
2 |
2 |
0 |
1 |
1 |
2 |
2 |
0 |
In Control area Dose: 0.5 ml of distilled water Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key: h = Hour.
Erythema Oedema
0 =No erythema 0 =No oedema
1 =Very slight erythema (barely perceptible) 1 =Very slight oedema (barely perceptible)
2 =Well defined erythema 2 = Slight oedema (edges of area well defined by definite raising)
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
1.00 |
2.00 |
2.00 |
Oedema |
1.00 |
1.33 |
1.67 |
Table 2: Individual Animal Body Weight
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
1.888 |
2.048 |
2 |
2.184 |
2.210 |
3 |
2.612 |
2.648 |
Table 3: Individual AnimalClinical Signs
Animal No. |
Days (Post dosing Observation) |
|||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- D
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of test chemical on eye, when exposed by the ocular route in rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Procured from Sainath Agencies, Hyderabad
- Age at study initiation: 2.5 to 3.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.596 kg and Maximum: 1.748 kg
- Housing: The animals were housed individually in stainless steel cages
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed minimum twice a week
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 200005.
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No. 2 and 3) prior to the application of the test item
- Identification : During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage card was labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.60 °C and Maximum: 22.20 °C
- Humidity (%): Minimum: 56.50 % and Maximum: 69.20%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): N/A
VEHICLE: N/A - Duration of treatment / exposure:
- 24 hr
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye of rabbit was washed with normal saline
- Time after start of exposure: 24 hrs
SCORING SYSTEM: Grading of irritation lesions was carried out as per Draize Method
TOOL USED TO ASSESS SCORE: ophthalmoscope - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control.
Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hour.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: No swelling (normal) was seen in all the animals.
Observation at 24, 48 and 72 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in all the animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels normal in all the animals; Chemosis: No swelling (normal) was seen in all the animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period (Refer Table 2).
Mortality
No mortality was observed during the observation period.
Body weight
All the rabbits increased body weight at 72 hours (termination) as compared to day 0 (Refer Table 3). - Interpretation of results:
- other: not irritating
- Conclusions:
- Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of New Zealand White female rabbits was observed at 72 hours.
Hence, the test chemical can be considered as not irritating to the eyes of New Zealand White female rabbits. - Executive summary:
Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 0.1 ml of test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions.
In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 which were recovered till 72 hours observation. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.
Reference
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose: 0.1 ml of test item (as such) Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||
Application Side |
Right |
Right |
Right |
||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Corneal Damage% |
0% |
0% |
0% |
Dose: Untreated (Control Eye) Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||
Application Side |
Left |
Left |
Left |
||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
* |
1 |
24 |
48 |
72 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Corneal Damage% |
0% |
0% |
0% |
Key:*= Pre-exposure eye examination
Table 1 (Continued): Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Corneal Opacity |
0.00 |
0.00 |
0.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
0.00 |
0.00 |
0.00 |
Chemosis |
0.00 |
0.00 |
0.00 |
Formula :
Mean Eye Irritation Score =
Sum of the Individual Animal Score for eye reaction at 24, 48 and 72 hours
Number of the Observations (3)
Table 2: Individual Animal Clinical Signs
Animal No. |
Days (Post application observation) |
|||
0 |
1 |
2 |
3 |
|
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 3: Individual Animal Body Weight
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
1.620 |
1.712 |
2 |
1.748 |
1.820 |
3 |
1.596 |
1.658 |
Key: kg = Kilogram
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with cotton soaked in distilled water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.
At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.
Eye irritation
Acute Eye Irritation/Corrosion Study of test chemical in Rabbits was performed as per OECD guideline no. 405. Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 0.1 ml of test item was instilled in the other (treated) eye of each rabbit. The eye was observed at 1, 24, 48 and 72 hours after test item instillation. Ophthalmoscope was used for scoring of eye lesions.
In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions till 24 hour observation hence a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 which were recovered till 72 hours observation. Untreated eye of all the three rabbits was normal throughout the experimental period of 72 hours. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 0% damage in animal no. 1, 2 and 3.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00; 0.00, 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, 0.00, respectively. Hence under the experimental test conditions, the test chemical can be considered as “Non Irritant” to New Zealand White female rabbit eyes.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical was observed in experimental studies. The results obtained from these studies indicate that the chemical is able to cause mild skin irritation but unlikely to cause eye damage. Hence the test chemical can be classified under the category “Category 2” for skin and “Not Classified” for eye as per CLP.
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