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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The follwoing mean scores were calculated for the individual examinations, performed 24, 48, 72 hours after patch removal in the test substance treated sites:

Erythema/eschar: 0.0 in ll animals

Oedema: 0.0 in all animals

The following mean scores were calculated for each animal from the individual examinations

Cornea: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Iris: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Conjunctivae, redness: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Conjunctivae, chemosis: 0.0 (24h); 0.0 (48h); 0.0 (72h)

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
Study period:
15. Sept 1998 to 18. Sept 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch: Ds 1099
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml Test substance
Duration of treatment / exposure:
4 hours
Observation period:
1h; 24h; 48h; 72h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
The follwoing mean scores were calculated for the individual examinations, performed 24, 48, 72 hours after patch removal in the test substance treated sites:
Erythema/eschar: 0.0 in ll animals
Oedema: 0.0 in all animals
Executive summary:

The follwoing mean scores were calculated for the individual examinations, performed 24, 48, 72 hours after patch removal in the test substance treated sites:

Erythema/eschar: 0.0 in ll animals

Oedema: 0.0 in all animals

The follwoing mean scores were calculated for the individual examinations, performed 24, 48, 72 hours after patch removal in the test substance treated sites:

Erythema/eschar: 0.0 in ll animals

Oedema: 0.0 in all animals

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15. Sept 1998 to 25. Sept 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch Ds02-01
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml test substance
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
The following mean scores were calculated for each animal from the individual examinations
Cornea: 0.0 (24h); 0.0 (48h); 0.0 (72h)
Iris: 0.0 (24h); 0.0 (48h); 0.0 (72h)
Conjunctivae, redness: 0.0 (24h); 0.0 (48h); 0.0 (72h)
Conjunctivae, chemosis: 0.0 (24h); 0.0 (48h); 0.0 (72h)
Executive summary:

The following mean scores were calculated for each animal from the individual examinations

Cornea: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Iris: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Conjunctivae, redness: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Conjunctivae, chemosis: 0.0 (24h); 0.0 (48h); 0.0 (72h)

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
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

Two studies have been preapred according to guideline. One for skin irritation, one for eye irritation. None of the animals showed signs of irritation neither on skin nor in eye. Therefore no classification is necessary.