Registration Dossier

Administrative data

Description of key information

Skin

The test material is not a dermal irritant in accordance with EU criteria.

Eye

The test material is not an eye irritant in accordance with EU criteria.

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 March 2006 to 23 March 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The skin irritation potential of three batches of the test material was assessed in the rabbit.
GLP compliance:
no
Species:
rabbit
Strain:
other: JW
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 male animals were exposed to three batches of test material
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was removed with lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM
The Draize scoring system was used. Reactions were assessed 1, 24, 48 and 72 hours after test material application.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
score of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
score of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
At the 24, 48 and 72 hour time points, no rabbit showed any reaction to the test material with regard to erythema and oedema formation. All scores were 0.

Table 1: Summary of Scores for the First Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

 

Table 2: Summary of Scores for the Second Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

 

Table 3: Summary of Scores for the Third Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

101

Erythema

0

0

0

0

Oedema

0

0

0

0

102

Erythema

0

0

0

0

Oedema

0

0

0

0

103

Erythema

1

0

0

0

Oedema

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions this study, the test material is not classified as a dermal irritant in accordance with EU criteria.
Executive summary:

A study was conducted to assess the potential of the test material to cause irritation to the skin of rabbits using methodology similar to that outlined in the standardised guideline OECD 404.

The skin irritation potential of three batches of the test material was assessed in 3 male JW rabbits. The dose level administered was 0.5 mL/2.5 x 2.5 cm site. Observations were made at 1 hour after exposure and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of skin reaction.

At the 24, 48 and 72 hour time points, no rabbit showed any reaction to the test material with regard to erythema and oedema formation. All scores were 0.

Under the conditions this study, the test material is not classified as a dermal irritant in accordance with EU criteria. 

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:
20 March 2006 to 23 March 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The eye irritation potential of three batches of the test material was assessed in the rabbit.
GLP compliance:
no
Species:
rabbit
Strain:
other: JW
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL/eye
Duration of treatment / exposure:
Eyes were closed for about 1 second after instillation.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male animals were exposed to each batch of test material (9 animals in total)
Details on study design:
SCORING SYSTEM
The Draize scoring system was used. Reactions were assessed 1, 24, 48 and 72 hours after test material application.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
score for all 9 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritant / corrosive response data:
At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.

Table 1: Summary of Scores for the First Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

601 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

602 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

603 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

 

Table 2: Summary of Scores for the Second Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

611 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

612 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

0

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

613 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

 

Table 3: Summary of Scores for the Third Batch of Test Material

Animal number

Observation

Time (hours)

1

24

48

72

621 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

622 (left eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

0

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

623 (right eye)

Cornea

0

0

0

0

Iris

0

0

0

0

Redness

1

0

0

0

Chemosis

0

0

0

0

Discharge

2

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria.
Executive summary:

A study was conducted to assess the potential of the test material to cause irritation to the eyes of rabbits using methodology similar to that outlined in the standardised guideline OECD 405.

The eye irritation potential of three batches of the test material was assessed in male JW rabbits (three per batch). The dose level administered was 0.1 mL/eye. The eyes of the rabbits were closed for about one second after instillation. Observations were made at 1 hour after instillation and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of eye reaction.

At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.

Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria. 

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was conducted to assess the potential of the test material to cause irritation to the skin of rabbits using methodology similar to that outlined in the standardised guideline OECD 404. The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The skin irritation potential of three batches of the test material was assessed in 3 male JW rabbits. The dose level administered was 0.5 mL/2.5 x 2.5 cm site. Observations were made at 1 hour after exposure and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of skin reaction.

At the 24, 48 and 72 hour time points, no rabbit showed any reaction to the test material with regard to erythema and oedema formation. All scores were 0.

Under the conditions this study, the test material is not classified as a dermal irritant in accordance with EU criteria. 

Eye

A study was conducted to assess the potential of the test material to cause irritation to the eyes of rabbits using methodology similar to that outlined in the standardised guideline OECD 405. The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The eye irritation potential of three batches of the test material was assessed in Male JW rabbits (three per batch). The dose level administered was 0.1 mL/eye. The eyes of the rabbits were closed for about one second after instillation. Observations were made at 1 hour after instillation and then every 24 hours for a total duration of 72 hours. The Draize scoring system was used to determine the degree of eye reaction.

At the 24, 48 and 72 hour time points, no eye in any rabbit showed any reaction to the test material with regard to the cornea, iris, redness, chemosis and discharge. All scores were 0.

Under the conditions this study, the test material is not classified as an ocular irritant in accordance with EU criteria. 

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the test material does not require classification for skin or eye corrosion/irritation.