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EC number: - | CAS number: -
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Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION/CORROSION
Non-irritant, reconstituted human epidermis (EPISKIN), eq. OECD 439, Warren (2008)
EYE IRRITATION/CORROSION
Irritating, rabbit, OECD 405, Zelenák (2013)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 June 2008 to 16 June 2008.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EPISKIN-SMTM Model supplied by SkinEthic Laboratories, Nice, France
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Pre-dates guideline inception
- Deviations:
- yes
- Remarks:
- Longer incubation time
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Signature: 15/10/2007; Date of Inspection: 21/08/2007
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg of the test material was applied to the epidermis surface.
VEHICLE
No vehicle was used. - Duration of treatment / exposure:
- The EPISKINTM reconstituted human epidermis model was subjected to treatment for a period of 15 minutes.
- Irritation / corrosion parameter:
- other: other: OD540 Value
- Value:
- 0.78
- Remarks on result:
- other:
- Remarks:
- Basis: mean Negative Control. Time point: 15 minutes. Max. score: 0.8. Remarks: Standard Deviation 0.014. (migrated information)
- Irritation / corrosion parameter:
- other: other: OD540 value
- Value:
- 0.09
- Remarks on result:
- other:
- Remarks:
- Basis: mean Positive control. Time point: 15 minutes. Max. score: 0.11. Remarks: Standard deviation 0.026. (migrated information)
- Irritation / corrosion parameter:
- other: other: OD540 value
- Value:
- 0.81
- Remarks on result:
- other:
- Remarks:
- Basis: mean Test Material. Time point: 15 minutes. Max. score: 0.84. Remarks: Standard deviation 0.03. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean tissue viability (%)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean Negative control. Time point: 15 minutes. Max. score: 102.0. Remarks: Standard deviation 1.81. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean Tissue viability (%)
- Value:
- 11.9
- Remarks on result:
- other:
- Remarks:
- Basis: mean Positive control. Time point: 15 minutes. Max. score: 13.9. Remarks: Standard deviation 3.35. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative mean tissue viability (%)
- Value:
- 103.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean Test material. Time point: 15 minutes. Max. score: 107.3. Remarks: Standard deviation 3.87. (migrated information)
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the relative mean viability of the test material treated tissues was 103.2 % after a 15 minute exposure. Since this was > 50 % the test material is considered to be a non-irritant, in accordance with the criteria for classification set out in the study.
- Executive summary:
The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTM reconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3‑[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-1α in the culture medium retained following the 42 hour post-exposure incubation period is also determined for test materials which are found to be borderline non-irritant based upon the MTT reduction endpoint. This complimentary end‑point will be used to either confirm a non-irritant result or will be used to override the non‑irritant result.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre‑labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT‑loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96‑well plate. The optical density was measured at 540 nm.
Data are presented in the form of % viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Under the conditions of the test, the relative mean viability of the test material treated tissues was 103.2 % after a 15 minute exposure. Since this was > 50 % the test material is considered to be a non-irritant.
Reference
RESULTS
Direct MTT Reduction
The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.
Test Material, Positive Control Material and Negative Control Material
The individual and mean OD540 values, standard deviations and tissue viabilities for the negative control, test material and positive control are given in Table 1. The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test material treated tissues was 103.2 % after a 15‑minute exposure.
The qualitative evaluation of tissue viability is given in Table 2.
Following the 15-minute exposure the test material treated tissues appeared blue which was considered indicative of viable tissue.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was ≤40 % relative to the negative control treated tissues and the Standard Deviation (SD) value of the % viability was ≤20 %. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the % viability was ≤20 %. The negative control acceptance criterion was therefore satisfied.
Table 1: Mean OD540 Values and % Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material |
OD540 of tissues |
Mean OD540 of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability |
Relative mean % viability |
± SD of % viability |
Negative |
0.799 |
0.783 |
0.014 |
102.0 |
100* |
1.81 |
0.772 |
98.6 |
|||||
0.777 |
99.2 |
|||||
Positive |
0.107 |
0.093 |
0.026 |
13.7 |
11.9 |
3.35 |
0.109 |
13.9 |
|||||
0.063 |
8.0 |
|||||
Test Material |
0.780 |
0.808 |
0.030 |
99.6 |
103.2 |
3.87 |
0.805 |
102.8 |
|||||
0.840 |
107.3 |
Table 2: Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Tissue 1 |
Tissue 2 |
Tissue 3 |
Negative Control Material Ä |
- |
- |
- |
Positive Control Material Ä |
+ |
+ |
+ |
Test Material |
- |
- |
- |
MTT
visual scoring scheme
- = blue
tissue (viable)
+ = blue/white
tissue (semi-viable)
++ = tissue
is completely white (dead)
* = The mean viability of the negative control tissues is set at 100%
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 February 2013 to 26 February 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with GLP and agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Justification for type of information:
- See Read-Across Justification in Section 13.
- Reason / purpose for cross-reference:
- other: Target record
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 3491 and 3551 g
- Housing: Individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbits in adjoining cages
- Diet: ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16.8 to 20.2 °C
- Humidity: 24 to 68 % (relative)
- Air changes: 15 to 20 changes per hour
- Photoperiod: 12 hour light/dark cycle (light from 06:00 to 18:00) - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated contralateral eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- pH: The pH of the test material was determined prior to dosing. The test material was found to be acceptable for use in the test (pH 5)
- TOPICAL ANAESTHETIC AND SYSTEMIC ANALGESIC
- Schedule: Sixty minutes (60 ± 10 minutes) prior to administration, a systemic opiate analgesic (Buprenorphine 0.01 mg/kg) was administered by subcutaneous injection. Five minutes (5 ± 1.5 minutes) prior to administration, a topical ocular anaesthetic (Humacain (oxybuprocaine) one-two drops per eye) was applied to each eye (including the control eye to ensure direct comparison of any ocular observations). Eight hours (8 to 9 hours) after test material application, Buprenorphine 0.01 mg/kg and a nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 0.5 mg/kg) were administered by subcutaneous injection. The systemic opiate analgesic was injected approximately every 12 hours and the NSAID every approximately every 24 hours until the ocular lesions were resolved and no clinical signs of pain or distress were present. - Duration of treatment / exposure:
- A single dose was administered
- Observation period (in vivo):
- 3 weeks (21 days)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: At the 1 and 24 hour observation point in one animal and at the 1 hour observation point only in the second animal.
SCORING SYSTEM: Draize (1977) and OECD 405.
The eyes were examined at in the first animal 1, 24, 48 and 72 hours, then 1, 2 and 3 weeks after treatment. The eyes were examined in the second animal 1, 24, 48 and 72 hours, then 1 and 2 weeks after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- For the irritant response of each animal, the mean score of the 24, 48 and 72 hour observations were calculated for each effect observed.
- Other effects:
- There was no mortality during the test. One animal showed slight bodyweight loss during the treatment period. The second rabbit was found to be within the normal range. There were no clinical signs observed that could be related to treatment.
No initial pain reaction was observed in either animal. - Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the test material caused eye irritation in two New Zealand White rabbits. The effects were found to be reversible within 21 days.
- Executive summary:
The eye irritation potential of the test material was investigated in New Zealand White rabbits in a study conducted in accordance with the standardised guideline OECD 405 under GLP conditions.
Two animals were exposed to the test material. 0.1 g of the test material was instilled into the conjunctival sac of the eye of each rabbit. The eyes were rinsed at the 1 and 24 hour examination points with physiological saline in one animal, and at the 1 hour observation point only in the second animal. Prior to dosing and during the observation period, a pain management regimen was administered (topical anaesthetic and systemic analgesic) which was continued until all eye effects had resolved. The animals were observed for up to 21 days, and any effects noted were evaluated in accordance with the Draize Scale (1977).
The animal individual mean scores (considering readings taken at 24, 48 and 72 hours after the treatment) were as follows:
Chemosis: 1.33 and 1.00
Discharge: 2.67 and 1.33
Redness: 1.33 and 2.00
Corneal opacity: 1.00 and 1.00
Iris: 0.00 and 0.00
There were no observed pain reactions related to the test material. One animal was reported to have a reduced bodyweight during the study.
Under the conditions of the study, the test material caused eye irritation in two New Zealand White rabbits. The effects were found to be reversible within 21 days.
Reference
Table 1: Results for Animal No. 01973
Time |
Irritation Score |
IPR/ PR |
||||||
Conjunctivae |
Cornea |
Iris |
Control eye |
|||||
R |
CH |
D |
OD |
OE |
||||
0 hours* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 hour |
2 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
24 hours |
2 |
2 |
3 |
1 |
3 |
0 |
0 |
0 |
48 hours |
1 |
1 |
3 |
1 |
3 |
0 |
0 |
0 |
72 hours |
1 |
1 |
2 |
1 |
3 |
0 |
0 |
0 |
7 days |
1 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
14 days |
1 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
21 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Pre-treatment
IPR/PR - Initial Pain Reaction/Pain Response
R – Redness
CH- Chemosis
D – Discharge
OD –Opacity (degree of density)
OE – Area of opacity
Table 2: Results for Animal No. 01950
Time |
Irritation Score |
IPR/PR |
||||||
Conjunctivae |
Cornea |
Iris |
Control eye |
|||||
R |
CH |
D |
OD |
OE |
||||
0 hours* |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 hour |
2 |
2 |
3 |
1 |
4 |
0 |
0 |
0 |
24 hours |
2 |
1 |
2 |
1 |
4 |
0 |
0 |
0 |
48 hours |
2 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
72 hours |
2 |
1 |
1 |
1 |
3 |
0 |
0 |
0 |
7 days |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
14 days |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
* Pre-treatment
IPR/PR - Initial Pain Reaction/Pain Response
R – Redness
CH- Chemosis
D – Discharge
OD –Opacity (degree of density)
OE – Area of opacity
Table 3: Results of Bodyweight Observations
Time point |
Bodyweight (g) |
Bodyweight gain (g) |
Animal no. 01973 |
||
Prior to treatment |
3491 |
325 |
21 February 2013 (16 days) |
3752 |
|
Termination of the study |
3816 |
|
Animal no. 01950 |
||
Before treatment |
3551 |
-1 |
Before euthanasia |
3550 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN IRRITATION
In the key study (Warren 2008), the irritation potential of the test material was assessed in vitro using the EPISKINTM reconstituted human epidermis model. The study was performed using methodology equivalent to the standardised guideline OECD 439 under GLP conditions.
Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre‑labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT‑loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96‑well plate. The optical density was measured at 540 nm.
Under the conditions of the test, the relative mean viability of the test material treated tissues was 103.2 % after a 15 minute exposure. Since this was > 50 % the test material is considered to be a non-irritant.
EYE IRRITATION
In the key study (Zelenák 2013), the eye irritation potential of a structural analogue of the registered material was investigated in New Zealand White rabbits in a study conducted in accordance with the standardised guideline OECD 405 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the principles for assessing data quality as described in Klimisch et al. (1997).
Two animals were exposed to the test material. 0.1 g of the test material was instilled into the conjunctival sac of the eye of each rabbit. The eyes were rinsed at the 1 and 24 hour examination points with physiological saline in one animal, and at the 1 hour observation point only in the second animal. Prior to dosing and during the observation period, a pain management regimen was administered (topical anaesthetic and systemic analgesic) which was continued until all eye effects had resolved. The animals were observed for up to 21 days, and any effects noted were evaluated in accordance with the Draize Scale (1977).
The animal individual mean scores (considering readings taken at 24, 48 and 72 hours after the treatment) were as follows:
Chemosis: 1.33 and 1.00
Discharge: 2.67 and 1.33
Redness: 1.33 and 2.00
Corneal opacity: 1.00 and 1.00
Iris: 0.00 and 0.00
There were no observed pain reactions related to the test material. One animal was reported to have a reduced bodyweight during the study.
Under the conditions of the study, the test material caused eye irritation in two New Zealand White rabbits. The effects were found to be reversible within 21 days.
In the supporting study (Warren 2008), the eye irritation potential of the test material was evaluated using the SkinEthic Reconstituted Human Corneal model (HCE, SkinEthic Laboratories) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death. The study was performed under GLP conditions, in line with good scientific principles but to a non-validated method. The study was therefore assigned a reliability score of 2 in accordance with the principles for assessing data quality as described in Klimisch et al. (1997).
For the main test, triplicate SkinEthic tissues were treated with 30 mg of the test material for 10 minutes. Triplicate tissues treated with 30 µL of Solution A served as the negative control and triplicate tissues treated with 30 µL of 1% w/v Sodium Dodecyl Sulphate served as the positive control. At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues. After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured (OD540).
Under the conditions of the test, the relative mean viability of the test material treated tissues was 66.7 % after a 10 minute exposure. Since this was > 60 % the test material is considered to be a non-irritant in accordance with the criteria for classification set out in the study. It was considered unnecessary to proceed with tissue histopathology.
Justification for selection of skin irritation / corrosion endpoint:
A single good quality in vitro study was performed under GLP conditions in line with good scientific principles. The study was performed using a methodology which was later adopted as a standard testing guideline. The method employed in the study was comparable to the adopted guideline with only one minor deviation (a slightly longer incubation time) which was not thought to affect the outcome of the results.
Justification for selection of eye irritation endpoint:
The key study was performed in vivo using a structural analogue of the registered material in accordance with the standardised testing guideline OECD 405. The study was reported to a high standard and performed under GLP conditions.
Effects on eye irritation: irritating
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008,the substance does not meet the criteria for classification for skin irritation.
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008,the substance should be classified for eye irritation as Category 2 (H319: Causes serious eye irritation) with the signal word warning and the pictogram GHS07.
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