Registration Dossier
Registration Dossier
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EC number: 701-257-8 | CAS number: -
Endpoint summary
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
- 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 for cross-reference:
- 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.
- 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 for cross-reference:
- 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 or test system 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
- 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.
Referenceopen allclose all
No skin irritating or corrosive effects observed.
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
- 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 for cross-reference:
- 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.
- 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.
Reference
Mesamoll was found to be not eye irritating.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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