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Description of key information

Skin irritation in vivo:

0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation (scores 0) was observed on the intact and scarificed skin at any time point.

Eye irritation in vivo:

100 mg test item was applied to the eye of a rabbit and animals were imnvestigated after 24, 48 and 72 h. Cornea, iris, conjunctivae and secretion observations were scored according to Draize. No effects (scores 0) were reported for all endpoints and all time points.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
No guideline followed but method is comparable to OECD TG 404 in principle.
Deviations:
yes
Remarks:
No guideline followed but method is comparable to OECD TG 404 in principle.
Principles of method if other than guideline:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
GLP compliance:
no
Specific details on test material used for the study:
Macrolex Rot 5B
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Body weight between 2.3 and 2.8 kg; 6 male and 6 female rabbits.
Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 ml test item (50% test item 50% water)
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
6 male and 6 female
Details on study design:
0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Other effects:
no effect on clinical observations, feed intake, body weight development

No irritation was observed on the intact and scarificed skin at any time point.

Interpretation of results:
GHS criteria not met
Conclusions:
No adverse effects observed. Not irritating.
Executive summary:

0.5 ml test item (50% test item 50% water) is applied to intact skin of 6 rabbits and scarificed skin of 6 rabbits (2.5 x 2.5 cm) for 24 h. Animals were observed for 14 days. Erythema and oedema were recorded according to Draize. No irritation was observed on the intact and scarificed skin at any time point.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
No guideline followed but method is comparable to OECD TG 405 in principle.
Deviations:
not applicable
Remarks:
No guideline followed but method is comparable to OECD TG 405 in principle.
Principles of method if other than guideline:
100 mg test item was applied to the eye of a rabbit and animals were imnvestigated after 24, 48 and 72 h. After 24 h fluorescein test was also performed. The cornea, iris, conjunctivae and secretion observations were scored according to Draize
GLP compliance:
no
Specific details on test material used for the study:
Macrolexrot 5B
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Body weight between 2.3 and 2.8 kg; 6 rabbits.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent vehicle
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48 and 72 h
Number of animals or in vitro replicates:
6 rabbits
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
No effects (scores 0) were reported for all time points.
Interpretation of results:
GHS criteria not met
Conclusions:
No adverse effects observed. Not irritating.
Executive summary:

100 mg test item was applied to the eye of a rabbit and animals were investigated after 24, 48 and 72 h. The cornea, iris, conjunctivae and secretion observations were scored according to Draize. No effects (scores 0) were reported for all endpoints and all time points.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No irritation (scores 0) were reported in early in vivo skin and eye irritation studies in rabbits. Classification is not warranted.