Registration Dossier
Registration Dossier
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EC number: 220-476-5 | CAS number: 2778-96-3
Endpoint summary
Administrative data
Description of key information
Skin irritation:
The dermal irritation potential of target chemical was assessed in various in-vivo experimental studies.Based on the available studies,it can be concluded that the test chemical 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 assessed in various in-vivo experimental studies.Based on the available studies,it can be concluded that the test chemical is unable 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''.
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:
- other: 2.mouse 3.rabbit 4.rat
- Strain:
- other: 2. not specified 3.not specified 4.Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- 2.No data available
3.not specified
4.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 212.7 to 250.8 grams at initiation of dosing.
Body weights at the start :
Male
Mean : 245.18 g (= 100 %)
Minimum : 236.8 g (- 3.42 %)
Maximum : 250.8 g (+ 2.29 %)
Total No. of animals : 5
Female
Mean : 218.66 g (= 100 %)
Minimum : 212.7 g (- 2.73 %)
Maximum : 222.2 g (+ 1.62 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 21.6 degree centigrade.
- Humidity (%): 55.0% to 58.4%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: 12-06-2017 to 27-06-2017 - Type of coverage:
- other: 2.not specified 3.occlusive 4.semiocclusive
- Preparation of test site:
- other: 2.hairless 3.clipped 4.clipped
- Vehicle:
- other: 2.oil (type not specified) 3.olive oil 4.Distilled water
- Controls:
- yes, concurrent vehicle
- not specified
- Amount / concentration applied:
- 2. 50% dilution in oil (type not specified)
3.40mg/ml in olive oil
4.TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): No data available
VEHICLE
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data available
- Concentration (if solution): No data available
POSITIVE CONTROL
- Amount(s) applied (volume or weight): No data available
- Concentration (if solution): No data available - Duration of treatment / exposure:
- 2.
2 times a day for 5 days
3. 24 hours
4. 24 hours - Observation period:
- 2.
5 days
3.
signs of irritation upon removal of the patches and at 48 and 72 hours.
4. 14 days - Number of animals:
- 2. 5
3.
Several rabbits (number not mentioned)
4. 10 (5/sex) - Details on study design:
- 2. no data available
3.
Details on study design
No data
SCORING SYSTEM: no data
4.
TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method.
OTHER OBSERVATIONS
Type and Frequency of Tests, Analyses and Measurements
Viability: Twice daily.
Clinical Observations and General Appearance:
Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Body weights:
Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:
Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed. - Irritation parameter:
- overall irritation score
- Remarks:
- 2.
- Basis:
- mean
- Time point:
- other: 5 days
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- 3.
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 4.
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 4.
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 2.No irritation was observed
3.No redness, swelling, or other signs of irritation were observed upon patch removal or at 48 and 72 hours
4.Overall result:
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days. - Other effects:
- 4.Other effects:
Clinical Signs of Toxicity and Mortality
Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Sex : Female
Group I -
Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Body Weight
Sex : Male
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.04% and 18.02% respectively.
Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.77% and 9.62% respectively.
Gross Pathological Findings
Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group. - 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:
The skin irritation potential of test chemical was assessed in mice. A 50% dilution in oil (type not specified) of test chemical was applied twice daily for 5 days to 5 hairless mice. The mice were observed for signs of irritation.Hairless mice did not show any signs of irritation after repeated exposure.Hence, the test material can be considered as not irritating to skin.
In another study, skin irritation potential of test chemical was assessed in rabbits. About 40 mg/mL of test substance in olive oil, was applied to the clipped skin of “several rabbits” where the material remained in place under a patch for 24 hours. Control rabbits received patches containing olive oil. The rabbits were observed for signs of irritation upon removal of the patches and at 48 and 72 hours. No redness, swelling, or other signs of irritation were observed upon patch removal or at 48 and 72 hours. Hence, the test substance can be considered as not irritating to rabbit skin.
Futhermore,a study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. This study was performed as per OECD guideline No. 402. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.Hence, it was concluded that test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested.
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
4.
Appendix No.I
Individual Animal -Clinical Signs of Toxicity and Mortality
Test System : Sprague Dawley Rat
Sex : Male
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
1 |
Day 0 - Day 14 |
0 |
2 |
Day 0 - Day 14 |
0 |
||||
3 |
Day 0 - Day 14 |
0 |
||||
4 |
Day 0 - Day 14 |
0 |
||||
5 |
Day 0 - Day 14 |
0 |
Sex : Female
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
5 |
6 |
Day 0 - Day 14 |
0 |
7 |
Day 0 - Day 14 |
0 |
||||
8 |
Day 0 - Day 14 |
0 |
||||
9 |
Day 0 - Day 14 |
0 |
||||
10 |
Day 0 - Day 14 |
0 |
Appendix No.II
Individual Animal - Evaluation of Dermal Reaction
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
6 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
10 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Appendix No.III
Individual Animal - Body Weight and Percent Body Weight Gain (g)
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
1 |
236.8 |
257.7 |
8.83 |
279.3 |
8.38 |
17.95 |
2 |
243.5 |
266.9 |
9.61 |
289.3 |
8.39 |
18.81 |
3 |
244.6 |
264.4 |
8.09 |
288.2 |
9.00 |
17.83 |
4 |
250.2 |
273.0 |
9.11 |
293.7 |
7.58 |
17.39 |
5 |
250.8 |
274.8 |
9.57 |
296.3 |
7.82 |
18.14 |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain Day 7- 14 |
% body weight gain day 0- 14 |
6 |
212.7 |
224.4 |
5.50 |
232.7 |
3.70 |
9.40 |
7 |
218.1 |
232.7 |
6.69 |
241.1 |
3.61 |
10.55 |
8 |
218.4 |
231.3 |
5.91 |
239.6 |
3.59 |
9.71 |
9 |
221.9 |
232.3 |
4.69 |
241.5 |
3.96 |
8.83 |
10 |
222.2 |
235.7 |
6.08 |
243.6 |
3.35 |
9.63 |
Appendix No.IV
Individual Animal - Gross Pathological Findings
Test System : Sprague Dawley Rat
Sex : Male
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
1 |
TS |
No abnormality detected |
2 |
TS |
No abnormality detected |
3 |
TS |
No abnormality detected |
4 |
TS |
No abnormality detected |
5 |
TS |
No abnormality detected |
Sex : Female
Group : I
Dose : 2000 mg/kg body weight
Animal No. |
Fate |
Gross Pathological Findings |
6 |
TS |
No abnormality detected |
7 |
TS |
No abnormality detected |
8 |
TS |
No abnormality detected |
9 |
TS |
No abnormality detected |
10 |
TS |
No abnormality detected |
TS = Terminal sacrifice
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 read across 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: 2.New Zealand Albino 3.not specified 4.Albino
- Details on test animals or tissues and environmental conditions:
- not specified
- Vehicle:
- other: 2.makeup foundation containing 0.05% Dilauryl thiodipropionate 3.unchanged (no vehicle) 4.unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 2.an unspecified amount of a makeup foundation containing 0.05% Dilauryl thiodipropionate
3.undiluted test chemical
4.100 % - Duration of treatment / exposure:
- 2.single exposure
3. 24 hours
4.3 days - Observation period (in vivo):
- 2.The rabbits were observed for signs of irritation (duration not mentioned).
3.24 hours
4.3 days - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 2. 9
3.no data available
4. 6 - Details on study design:
- 2.no data available
3.SCORING SYSTEM: Draize scores
4.Details on washing:
The eyes were unwashed throughout the study - Irritation parameter:
- overall irritation score
- Remarks:
- 2.
- Basis:
- mean
- Time point:
- other: Not specified
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- 3.
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- 4.
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 2. None of the rabbits had ocular reactions to the test material at any of the observation times
3. The 24 hours Draize scores of 2, 4, 6 out of a maximum 110.No irritation was observed at later evaluations.
4.No signs of irritation observed.The overall irritation score of the test chemical was 0 on Days 1, 2, and 3,respectively - 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:
The eye irritation study of similar read across substance was assessed in rabbits according to Modified Draize method.An unspecified amount of a makeup foundation containing 0.05% of test substance was instilled into the eyes of 9 albino New Zealand White rabbits. The rabbits were observed for signs of irritation (duration not mentioned).
None of the rabbits had ocular reactions at any of the observation times. Hence, the makeup foundation containing 0.05% of test material was considered as not irritating to rabbit eyes under the conditions of the study.
The above result was supported by an eye irritation study of another read across substance in rabbits.Undiluted test chemical was instilled into rabbit eyes and scored at 24 hours according to Draize method. Undiluted substance caused slight, transient ocular irritation in rabbits. The 24 hours Draize scores of 2, 4, 6 out of a maximum 110.No irritation was observed at later evaluations.Since, no irritation was observed after 24 hours, therefore undiluted test chemical was considered as not irritating to rabbit eyes.
Moreover,in another ocular irritation study which was conducted to evaluate the ocular irritation potential of the test chemical according to Draize method. 6 albino rabbits were used for the study. Undiluted test chemical was instilled into the eyes of rabbits and the eyes remained unwashed.The reactions observed were scored after 1,2,3 days according to Draize method.The overall irritation score of the test chemical was 0 on Days 1, 2, and 3,respectively. Based on the overall irritation score after 3 days, test chemical can be considered not irritating to 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”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Various studies were performed on rabbits to assess the dermal irritation potential of test chemical which have been summarized as follows:
The skin irritation potential of test chemical was assessed in mice. A 50% dilution in oil (type not specified) of test chemical was applied twice daily for 5 days to 5 hairless mice. The mice were observed for signs of irritation.Hairless mice did not show any signs of irritation after repeated exposure.Hence, the test material can be considered as not irritating to skin.
In another study, skin irritation potential of test chemical was assessed in rabbits. About 40 mg/mL of test substance in olive oil, was applied to the clipped skin of “several rabbits” where the material remained in place under a patch for 24 hours. Control rabbits received patches containing olive oil. The rabbits were observed for signs of irritation upon removal of the patches and at 48 and 72 hours. No redness, swelling, or other signs of irritation were observed upon patch removal or at 48 and 72 hours. Hence, the test substance can be considered as not irritating to rabbit skin.
Futhermore,a study was designed and conducted to determine the dermal reaction profile of test chemical in Sprague Dawley rats. This study was performed as per OECD guideline No. 402. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was moistened with distilled water. The test item was applied onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.Hence, it was concluded that test chemical was Non-Irritating to the skin of Sprague Dawley rats under the experimental conditions tested.
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”.
Eye Irritation:
Various studies were performed on rabbits to assess the ocular irritation potential of test chemical which have been summarized as follows:
The eye irritation study of similar read across substance was assessed in rabbits according to Modified Draize method. An unspecified amount of a makeup foundation containing 0.05% of test substance was instilled into the eyes of 9 albino New Zealand White rabbits. The rabbits were observed for signs of irritation (duration not mentioned). None of the rabbits had ocular reactions at any of the observation times. Hence, the makeup foundation containing 0.05% of test material was considered as not irritating to rabbit eyes under the conditions of the study.
The above result was supported by an eye irritation study of another read across substance in rabbits. Undiluted test chemical was instilled into rabbit eyes and scored at 24 hours according to Draize method. Undiluted substance caused slight, transient ocular irritation in rabbits. The 24 hours Draize scores of 2, 4, 6 out of a maximum 110.No irritation was observed at later evaluations. Since, no irritation was observed after 24 hours, therefore undiluted test chemical was considered as not irritating to rabbit eyes.
Moreover,in another ocular irritation study which was conducted to evaluate the ocular irritation potential of the test chemical when used in a cosmetic formulation. The test chemical was applied as 10% in eye shadow formulation to the eyes of 6 rabbits (duration of exposure not specified) and the effects were observed.The overall irritation score of the test chemical was 0 in all animals at 24, 48, and 72 hrs.Based on the overall irritation score, the test chemical can be considered not irritating to 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”.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical was observed in various studies. The results obtained from these studies indicate that the chemical is not likely to cause skin and eye irritation. Hence the test chemical can be classified under the category “Not Classified” for skin and eye irritation as per CLP.
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