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Administrative data

Description of key information

Makrolex Rot EG is not irritating to the skin nor to the mucous membranes of the eyes of rabbits

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: similar to respective guideline but reported only in brief
Principles of method if other than guideline:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: oil
Controls:
other: the opposite side served as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
Irritation parameter:
other: irritational effects: scarificed skin
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: irritational effects: intact skin
Basis:
mean
Time point:
other: up to 7 days
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
72 hours post application, only the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (score 2/4) which were fully reversible within 7 days. Intact skin showed no reaction. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits

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: similar to respective guideline but reported only in brief
Principles of method if other than guideline:
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
one left eye : due to rinsing: 1 min, the other left eye was not rinsed
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days.
Irritation parameter:
other: irritational effects
Basis:
mean
Time point:
other: up to 8h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: slight conjunctival injections which do not lead to classification
Irritant / corrosive response data:
After 4 hours and after 8 hours slight conjunctival injections and slight discharge was observed. Within 24 hours both left treated eyes cleared and dis charge ceased wether it was rinsed eye or not-rinsed eye. Fluorescein test was without finding.
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days. Four hours and 8 hours post application slight irritating effects were observed which were fully reversible within 24 hours, thus, not leading to classification. In addition, Fluorescein Test was without finding. Therefore, the overall evaluation is that Macrolex Rot is not irritating to the eyes of rabbits.

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

Additional information

SKIN IRRITATION

Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits

EYE IRRITATION

100 mg of the test substance was applied into the concunctival sac of the left eye of each of 2 rabbits. After one minute the left eye of one of the two rabbits was rinsed with physiological saline. The right eyes of each of the two rabbits served as control. The animals were observed for 7 days. Four hours and 8 hours post application slight irritating effects were observed which were fully reversible within 24 hours, thus, not leading to classification. In addition, Fluorescein Test was without finding. Therefore, the overall evaluation is that Macrolex Rot is not irritatin to the eyes of rabbits.


Justification for selection of skin irritation / corrosion endpoint:
This is the only availble study

Justification for selection of eye irritation endpoint:
this is the only available study

Justification for classification or non-classification

Based on the available data no classification or labelling is required.