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Administrative data

Description of key information

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:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
24 hour occlusive exposure with observations at 24 and 48 hours after start of exposure.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of the pure substance
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
6 (male)
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.83
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.33
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Erythema:
At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction
At 48 hours 4 animals had no reaction and 2 animals had a slight reaction

Edema
At 24 hours 1 animal had a slight reaction and 5 had no reaction
At 48 hours no animals had reactions.

This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.

Erythema:

At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction

At 48 hours 4 animals had no reaction and 2 animals had a slight reaction

Edema

At 24 hours 1 animal had a slight reaction and 5 had no reaction

At 48 hours no animals had reactions.

This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.

Interpretation of results:
not irritating
Conclusions:
This substance produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
Executive summary:

Doses of 0.1ml of test compound applied to intact skin of rabbits under 1 1/2 inch by 1 1/2 inch, 12 -ply gauze squares. Rubber sheeting was then loosely wrapped around the trunk and secured with tape. After 24 hours the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours. Erythema and edema were scored qualitatively as negative, slight, mild, moderate or severe.

This substance  produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling 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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test material dosed into right eye of 2 rabbits. 20 seconds after treatment one treated eye was washed. Observations of cornea, iris and conjunctiva made at 1 and 4 hours and 1, 2, 3, 7 and 15 days post treatment.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1 rabbit - 20 seconds
1 rabbit - 1 minute
Observation period (in vivo):
1h, 4h, 1, 2, 3, 7 and 15 days
Number of animals or in vitro replicates:
2 (males)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
uwashed eye
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 15 days
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
7 d
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 15 days
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
14 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 15 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
7 d
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 15 days
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 15 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed eye
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed eye
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
washed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
washed eye
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 1 day
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
washed eye
Time point:
other: 4 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
unwashed eye
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
unwashed eye
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: one day
Remarks on result:
no indication of irritation

Unwashed eye:

Cornea: some slight clouding at 1h, 4h and 3 -7 days. Small area of slight clouding at days 1 and 2. No effects apparent at 15 days

Iris: Slight swelling at days 2 -3 only

Conjunctiva: mild redness at day 1 only; slight swelling at 4 hrs and day 1; mild discharge at 4 hr and 3 days

All effects resolved by day 7 or 15.

Washed eye:

Cornea: local area of slight clouding at 1hr and 1 day only

Iris: No effects

Conjunctiva: No redness, Slight swelling at 1 and 4 hours; mild discharge at 4 hours only

Overall there were minimal signs of irritation in each animal. These effects do not appear to be significant or sufficiently severe to warrant classification for eye irritation.

Interpretation of results:
not irritating
Conclusions:
Although signs of mild irritation were observed they appear to be slight/mild and do not appear to meet the criteria for classification as irritating to the eyes.
Executive summary:

1/10 ml of undiluted material dosed to the conjunctival sac of the right eye of each of two rabbits. At 20s after dosing the treated eye of one rabbit was washed with tap water for 1 minute. The treated eye of the second rabbit remained unwashed. Observations of the cornea, iris and conjunctiva were made as indicated above. Draize scoring was not used, instead the effects were marked qualititatively. Although signs of mild irritation were observed they appear to be slight/mild and do not appear to meet the criteria for classification as irritating to the eyes.

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

Respiratory irritation

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

Additional information

Skin: in a well conducted skin irritation study this substance failed to produce signs of irritation.

Eye: in a well conducted eye irritation study this substance produced some minimal signs of irritation but they did not persist nor were they sufficient for classification.

Respiratory: no data are available for this substance. Data on the available read across substances (dimethyl esters) indicate that there are some signs of histopathological signs of local irritation in the upper respiratory tract in animals dosed via the inhalation route. There were no changes in breathing pattern associated with these changes. This substance also has a higher vapour pressure than the diisobutyl esters and so potential for inhalation exposure leading to irritation is minimal. There are also no evidence in humans of respiratory irritation when handling this material. Therefore this substance is not considered to be a respiratory irritant.

Justification for classification or non-classification

Criteria for classification not met. Therefore no classification required.