Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

SKIN
Not irritating, Annex V
EYES
Not irritating, Annex V

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 December 1989 to 31 January 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Vehicle:
other: The test material as supplied was moistened with 0.5 mL of distilled water.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 hours
Number of animals:
6 animals
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period:
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 days
Other effects:
Slight erythema (score 1) was observed in 3 out of 6 animals at 1 hour only.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was concluded to be not irritating to the skin.
Executive summary:

The skin irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study the skin of 6 New Zealand White rabbits was exposed to 500 mg of test material moistened with 0.5 mL of distilled water, under occlusion, for a period of 4 hours.

Slight erythema (score 1) was observed in 3 out of 6 animals; all changes were fully reversible within 1 day.

Therefore, under the conditions of the study, the test material was concluded to be not irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 July 1999 to 18 July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 91 mg (equivalent to 0.1 mL)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.7
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.7
Max. score:
2
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.3
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.3
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
No corneal or iridial effects were noted during the study.
Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation.
All eyes appeared normal at the 72-hour observation.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test material was determined to be non-irritating to the eyes.
Executive summary:

The eye irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study 91 mg of test material was instilled in the eyes of 3 New Zealand White rabbits. Signs of ocular irritation were observed over a period of 72 hours.

No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. All eyes appeared normal at the 72-hour observation.

Under the conditions of the study the test material was determined to be non-irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

The skin irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study the skin of 6 New Zealand White rabbits was exposed to 500 mg of test material moistened with 0.5 mL of distilled water, under occlusion, for a period of 4 hours.

Slight erythema (score 1) was observed in 3 out of 6 animals; all changes were fully reversible within 1 day.

Therefore, under the conditions of the study, the test material was concluded to be not irritating to the skin.

The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality as set forth in the publication by Klimisch et al (1997).

Eyes

The eye irritation potential of the test material was investigated in a study which was conducted under GLP conditions.

During the study 91 mg of test material was instilled in the eyes of 3 New Zealand White rabbits. Signs of ocular irritation were observed over a period of 72 hours.

No corneal or iridial effects were noted during the study. Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation. All eyes appeared normal at the 72-hour observation.

Under the conditions of the study the test material was determined to be non-irritating to the eyes.

The study was assigned a reliability score of 1 in accordance with the principles for assessing data quality as set forth in the publication by Klimisch et al (1997).


Justification for selection of skin irritation / corrosion endpoint:
Only one study is available.

Justification for selection of eye irritation endpoint:
Only one study is available.

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 require classification with respect to either skin or eye irritation.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to either skin or eye irritation.