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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
November 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed in accordance with GLP and following OECD guidelines.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 animals of one sex were used.
Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
Test substance was ground to a powder usign a pestle and mortar prior to weighing and the test substance was moistened with 0.4ml water (Mill-U) immediately before application to ensure close contact with the animals skin.
0.5g of test substance was applied.
Duration of treatment / exposure:
Four hours after the application of test substance, the dressing was removed and the skin cleaned of residual test substance using water.
Observation period:
Mortality / Viability: Twice daily.
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
Number of animals:
3 animals of one sex.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
Animal #925
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
Animal #926
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
Animal #927
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
Animal #925
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
Animal #926
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
Animal #927
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to SETAFIX X 11342
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Guideline in commission Directive 93/21/EEC
Conclusions:
No skin irritation was caused by 4 hours exposure to SETAFIX X 11342.
Executive summary:

No skin irritation was caused by 4 hours exposure to SETAFIX X 11342

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Carried out to GLP standards and according to OECD guidelines
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals used within the study were at least 6 weeks old and body weights were between 1.0 and 3.5Kg.
Identification: Earmark
Vehicle:
unchanged (no vehicle)
Remarks:
Test substance (solid) was ground to a powder prior to weighing.
Controls:
not required
Amount / concentration applied:
72.0+/-0.3mg of test substance was applied.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instiallation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
Number of animals or in vitro replicates:
Three animals
Details on study design:
The irritation was assessed according to a numerical scoring system for
Corneal Irritation - Opacity and area
Iris
Conjunctival irritation - redness, chemosis and discharge

Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an opthalmic examination lamp.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours in one animal and 72 hours in the other animals
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
24 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 2 out of 3 animals had a max score of 1 at 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
48 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 2 out of 3 animals had a max score of 1 at 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of three animals
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Corrosion: There was no evidence of ocular corrosion.

Colouration: No staining of (peri) ocular tissues by the test substance was observed.

Remnants of the test substance were present in the eyes of all animals on day 1.

Toxicity/ mortality: No symptoms of sytemic toxicity were observed in the animals during the test period and no mortaility occured.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

Based on these results and according to the EC criteria for classification and labelling requirments for dangerous substances and preparations, SETAFIX X 11342 does not have to be classified and has no obligatory labelling requirement for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
No skin irritation effects were seen after 24 hours exposure.

Justification for selection of eye irritation endpoint:
No eye irritation was seen beyond 48 hours in all cases and all effects were fully reversed within 72 maximum for all test animals.

Justification for classification or non-classification

No skin irritation effects were seen after 24 hours exposure.

No eye irritation was seen beyond 48 hours in all cases and all effects were fully reversed within 72 maximum for all test animals.