Registration Dossier

Administrative data

Description of key information

not skin irritant
not eye irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
other: solution at 0.9% NaCl
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
3 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
1

Form of application: To the intact, shorn skin in the dorsal region of the trunk (area 25 cm2). Type and duration of the signs of irritation: One hour after the removal of the plaster the skin of the animals revealed hardly perceptible to clearly outlined erythema. Very slight oedema was observed in two animals. 24 to 48 hours after the removal of the plaster the skin still exhibited hardly perceptible erythema. 72 hours after the removal of the plaster, all of the animals were free from signs of irritation.

Interpretation of results:
not classified
Remarks:
Migrated information under Regulation 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.
Executive summary:

The substance was tested following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean value 24, 48 and 72h
Score:
ca. 0.3
Max. score:
1
Other effects:
Clear conjunctival chemosis was observed in the animals one hour p.a. Due to dye depositions, conjunctival redness and inflammation of the iris could not be assessed at this point in time. In addition, a lilac efflux caused by the substance occurred.24 h p.a. the conjunctivae of all of the animals exhibited clear hyperaemia in some blood vessels and slight chemosis.The iris was reddened.As from 24 h p.a. all of the animals were free from signs of irritation. In addition to the signs of irritation which occurred, as from 24 h p.a. the iris, conjunctivae and nictitating membrane, and as from 48 hours p.a. the eyeball too, were discolored by the substance
Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation properties
Executive summary:

The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation properties

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The analogue substance was tested for skin and eye irritation following OECd 404 and 405 respectively (NONS dossier, 1988). In vivo results are available showing no irritating potential for skin and eye.

Based on the read across considerations the same results apply to Reactive Red 239:1.

Justification for classification or non-classification

Under Regulation 1272/2008:

a substance is classified as skin irritant Cat 2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

A substance is classified as:

Eye irritant Cat 2: if at least in 2 of 3 tested animals, a positive response of:

1)    corneal opacity ≥ 1 and/or

2)    2) iritis ≥ 1, and/or

3)     conjunctival redness ≥ 2 and/or

4)     conjunctival oedema (chemosis) ≥ 2

5)    calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

Based on the results of the in vivo studies performed on the analogue substance and the read across considerations, the substance is not classified for skin and eye irritation