Registration Dossier

Administrative data

Description of key information

In-vivo, the substance was slightly irritant to skin and produced in eyes minimal transient conjunctival reactions within 24 hour after test treatment.

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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Table 7.3.1.1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 2

Max. score: 0

24 h

0/2/0 

 0/0/0 

48 h

 0/0/0 

 0/0/0 

72 h

 0/0/0 

 0/0/0 

Average 24h, 48h, 72h

 0.0/0.67/0.0

 0.0/0.0/0.0

Reversibility*)

 C

 -

Average time (unit) for reversion

Within 48 hours 

 -

C: Completely reversible

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:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Species:
rabbit
Strain:
New Zealand White
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: at 48 hour observation period
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: at 48 hour observation period
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Other effects:
None

7.3.2.1 Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

 1/2/2

0/0/0

24 h

0/0/0

0/0/0

0/1/1 

0/0/0

48 h

 0/0/0

 0/0/0

0/0/0 

 0/0/0

72 h

0/0/0 

0/0/0 

0/0/0 

0/0/0 

Average 24h, 48h, 72h

0.0/0.0/0.0

0.0/0.0/0.0

0.0/0.3/0.3 

0.0/0.0/0.0

Reversibility*)

-

 -

 C

-

Average time (unit) for reversion

-

 -

 48h

 -

C: completely reversible

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

The potential of the test item to induce skin irritation was assessed in 3 rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practices.

A quantity of 0.5 g/flank was applied to a skin area under a semi-occlusive dressing for 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal only 24 hours after patch removal. No dermal irritation was observed in the two remaining animals throughout the observation period.

 The mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.67, 0.0 for erythema and 0.0, 0.0; 0.0 for oedema.

Eye irritation / corrosion:

The potential of the test item to induce eye irritation was assessed in rabbits according to OECD Guideline 405 in compliance with Good Laboratory Practice.

A volume of 0.1 mL of the test substance was placed into the conjunctival sac of one eye of three New Zealand White rabbits. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/ irritation was made 1, 24, 48 and 72 hours following treatment according to the Draize scoring method. Since all animals showed no evidence of irritation after 72 hours, the evaluation of ocular reactions was stopped.The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

No corneal damage or iridial inflammation was observed. Conjunctival inflammation was observed in all animals with a maximum score of 2 but resolved within 48 hours after dosing. The mean individual scores were 0.0,0.3,0.3 for conjunctival redness and 0.0,0.0,0.0 for chemosis, corneal and iridial lesions.


Justification for classification or non-classification

Based on the results from in vivo studies, the substance is not classified as a skin or eye irritant according to regulation EC No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.