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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 irriation/corrosion: Not irritating (84/449/EEC,B.4/ GLP)
Serious eye damage/eye irritation: Not irritating (84/449/EEC,B.5/ GLP)

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC,B.4
GLP compliance:
yes
Species:
other: rbt,New Zealand White,Chbb:NZW
Type of coverage:
semiocclusive
Vehicle:
other: none
Duration of treatment / exposure:
4 h
Observation period:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, and 72h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48, and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, and 72h
Score:
0.33
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48, and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, and 72h
Score:
0
Irritation parameter:
edema score
Max. score:
1
Remarks on result:
other: Max. duration: 1 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Reversibility of any observed effect: Changes not fully reversible within 1 days
Interpretation of results:
other: not classified
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC, B.5
GLP compliance:
yes
Species:
other: rbt, New Zealand White, Chbb:NZW
Amount / concentration applied:
0.1 ML
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Irritation parameter:
conjunctivae score
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at the 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 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 24h; Max. value at the 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 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 24h; Max. value at the end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at the end of observation period: 0 (related to all animals)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irriation/corrosion

Two skin irritation in vivo studies carried out in the rabbit were available.

In the supporting study (Annex V, GLP), 3 rabbits (New Zealand White) were dermally exposed (occlusive) to 0.5mL of the test substance for 4 hrs. Erythema (max score: 1, fully reversible within 1 day) was indicated but no odema.In the primary dermal irritation key study (84/449/EEC,B.4/ GLP), 3 rabbits (New Zealand White) were dermally exposed (semi-occlusive) to 0.5mL of the test substance for 4 hrs. Erythema (max score: 1, fully reversible within 2 days) and odema (max score 1, changes not fully reversible within 1 day). The substance was considered non-irritating in both in vivo skin irritation/corrosion tests.

Serious eye damage/eye irritation

Two eye irritation in vivo studies carried out in the rabbit were available. In the supporting study (Annex V, GLP), 0.1mL mg test substance was instilled into the eye of 3 rabbits (New Zealand White). The following effects were noted: conjunctival redness (max score: 2; fully reversible within 10 days); chemosis (max score: 1; max. duration: 24hrs); cornea (max score: 1; max. duration: 24hrs); no iris irritation noted. The observation period was extended to 10 days in order to determine recovery from the observed effects of the treatment. In a primary eye irritation key study (84/449/EEC. B.5/GLP), 0.1mL mg test substance was instilled into the eye of 3 rabbits (New Zealand White). The following effects were noted: conjunctival redness (max score: 1; fully reversible within 10 days); chemosis (max score: 1; max. duration: 24hrs), cornea (max score: 1; max. duration: 24hrs); no iris irritation noted. The observation period was extended to 10 days in order to determine the reversibility of the reactions. The maximum duration in the case of conjunctival redness amounted to 10 days. The substance was considered non-irritating in both the in vivo eye irritation tests when compared to the classification criteria in the CLP Regulation.


Justification for selection of skin irritation / corrosion endpoint:
There is more information provided in the results of the key study and the dermal coverage was semi-occlusive which is indicated in the OECD 404
guideline.

Justification for selection of eye irritation endpoint:
There is more information provided in the results of the key study.

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 5599 (CAS No. 127519-17-9) does not need to be classified for skin irritation/corrosion or eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.