Registration Dossier

Administrative data

Description of key information

There are no studies available performed according to current guidelines. Based on older data with rabbits (limited documentation), ATBC gave no indication for skin irritating effects, but was considered as a slight eye irritant. However, irritation scores are all below cut-off values determined for eye irritants.

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:
presumably 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only results given. Publication has lack of methodical details
Qualifier:
no guideline followed
Principles of method if other than guideline:
1.)
3 male albino rabbits were used. The abdomen were closely clipped and 1 mL/kg bw was placed on the intact skin daily for 4 days. The animals were observed daily and for a period of 36 h after the last application.

2.)
3 male albino rabbits were used. 1 mL/kg was placed on the closely clipped abdomen for a total of 18 applications (6 d per week). Animals were observed daily and for a period of two weeks following the last application.

3.)
Abraded skin:
2 male albino rabbits were used. 1 mL/kg was placed on the closely clipped abdomen for a total of 18 applications (6 d per week). Animals were observed daily and for a period of two weeks following the last application.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
no further data
Type of coverage:
not specified
Preparation of test site:
other: intact / abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
1 mL/kg bw (ca. 1000 mg/kg)
Duration of treatment / exposure:
4 - 18 applications
Observation period:
36 h to 2 weeks after last application
Number of animals:
2-3
Details on study design:
see above
Irritation parameter:
overall irritation score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritant effects noted

Individual scores were not given. Examination time points: 36 h to 2 weeks after last application.

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In all of the 3 trials there was no indication for skin irritation.

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:
presumably 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methodical details are missing
Qualifier:
no guideline followed
Principles of method if other than guideline:
3 male albino rabbits were used. 0.1 mL was instilled once into the left conjunctival sac, while the right eyes were used as controls. Observations were made at 20 min and at 3 – 72 h after application.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
not specified
Controls:
other: right eyes were used as controls
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
Observations were made at 20 min and at 3 – 72 h after application.
Number of animals or in vitro replicates:
3 m
Details on study design:
SCORING SYSTEM: no data
Irritation parameter:
overall irritation score
Remarks on result:
other: slight irritation was observed

Within 20 min moderate erythema in 2/3 rabbits, which persisted at the 3 h observation period and subsided in 1 of the 2 two rabbits after 5 hours. At 24 h moderate erythema in one rabbit was slightly increased, while the other two rabbits were negative. At 48 and 72 h all the eyes were essentially negative.

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
ATBC was slightly eye irritating
Executive summary:

3 male albino rabbits were used. 0.1 mL was instilled once into the left conjunctival sac, while the right eyes were used as controls. Observations were made at 20 min and at 3 – 72 h after application.

Within 20 min moderate erythema in 2/3 rabbits, which persisted at the 3 h observation period and subsided in 1 of the 2 two rabbits after 5 hours. At 24 h moderate erythema in one rabbit was slightly increased, while the other two rabbits were negative. At 48 and 72 h all the eyes were essentially negative.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

There are no studies available performed according to current guidelines. Based on older data (Morflex, no dated) with limited documentation, ATBC gave no indication for skin irritating effects, but was considered as a slight eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
Available study.

Justification for selection of eye irritation endpoint:
Available study.

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

As no skin irritation was observed, ATBC is not considered subject for classification for skin irritation. ATBC was slightly eye irritating, however all effects such as erythema were reversible within 48 h after treatment.