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Administrative data

Description of key information

In a skin irritation/corrosion study in 7 human volunteers (no sex defined) the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation period was 7 days. No skin irritating or corrosive effects could be observed (Löser E./ Kimmerle G., Bayer AG, 1975).
In an irritation/corrosion study 2 New Zealand White rabbits (male and female) were treated with the testsubstance as follows: the test substance was applied in a dose of approximatively 500 µl onto the skin of the ear and fixed with an adhesive bandage for 24 hours. The observation period was 7 days. No signs of irritation or corrosion could be observed (Löser E./ Kimmerle G., Bayer AG, 1975).
In an eye irritation study the test substance was applied to the conjunctival sack of rabbits (no nr.of animals given) in a dose of 100 µl. During the 7 days of observation time no changes of the mucous membrane, iris and cornea could be observed. Mesamoll was found to be not eye irritating (Löser E./ Kimmerle G., Bayer AG, 1975).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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: No OECD guideline study or GLP defined, no data on purity of test sample, no dose defined, no sex defined.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Method: other: human n=7, saturated patch, right forearm, 24 h exposure, observation period: 7 days
GLP compliance:
not specified
Species:
human
Strain:
not specified
Type of coverage:
other: ball of absorbent cotton and adhesive bandage
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: no control test persons described
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
7 test persons
Irritation parameter:
overall irritation score
Basis:
other: 7 volunteers
Time point:
other: 8 h
Score:
ca. 0
Max. score:
8
Reversibility:
other: no effects observed
Remarks on result:
other: In a study in 7 humans the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation:7d. No skin irritating or corrosive effects could be observed.

No skin irritating or corrosive effects observed.

Interpretation of results:
GHS criteria not met
Executive summary:

In a study in 7 humans (no sex defined) the test substance (no dose defined) was applied to the right forearm and fixed with a ball of absorbent cotton and adhesive bandage for 24 hours. The observation period was 7 days. No skin irritating or corrosive effects could be observed.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined; no data on purity of test sample
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Method: other: 500 µl on the ear of two rabbits, 24 h exposure, observation period: 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
3-4 kg bw.
Type of coverage:
other: adhesive bandage
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
2
Remarks on result:
other: see: executive summary

No signs of irritation or corrosion could be observed.

Executive summary:

In this irritation/corrosion study 2 New Zealand White rabbits (male and female) were treated with the testsubstance as follows:

the test substance was applied in a dose of approximatively 500 µl onto the skin of the ear and fixed with an adhesive bandage for 24 hours. The observation period was 7 days. No signs of irritation or corrosion could be observed.

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: No OECD guideline or GLP defined; no data on purity of test sample; no data on no.of animals used.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Method: 100 µl, eye, observation period: 7 days
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
ca. 0
Max. score:
110
Reversibility:
other: no effects observed
Remarks on result:
other: In this eye irritation study the test substance was applied to the conjunctival sack of rabbits (no nr.of animals given) in a dose of 100 µl. During the 7 days of observation time no changes of the mucous membrane, iris and cornea could be observed.

Mesamoll was found to be not eye irritating.

Interpretation of results:
GHS criteria not met
Executive summary:

In this eye irritation study the test substance was applied to the conjunctival sack of rabbits (no nr.of animals given) in a dose of 100 µl.

During the 7 days of observation time no changes of the mucous membrane, iris and cornea could be observed.

Mesamoll was found to be not eye irritating.

The NOEL therefore is 100 µl.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Conclusion: No skin irritation/corrosion in human or rabbits could be observed. No eye irritation in rabbits could be observed.

Justification for classification or non-classification

Classification is not required.