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Diss Factsheets

Administrative data

Description of key information

Not irritant to skin.


Irreversible eye damage.

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:
From April 18th to 25th, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
July 31st, 1992
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 17th, 1992
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
test substance was moistened with bi-distilled water before application.
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 hours after the removal of the dressing, guaze patch and test substance.
Number of animals:
3 animals: 1 male, 2 females
Details on study design:
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures.
To classify the irritating potential of the test article, the mean values of erythema/eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Commission Directive 93/21/EEC, April 27th, 1993).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
COLORATION: blue to light blue staining by the test substance of the treated skin was observed.
CORROSION: no irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
MORTALITY: no mortality occured.
Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008).
Conclusions:
Not irritant to skìn.
Executive summary:

The study procedures described in this report are based on the OECD Guideline 404 adopted July 17th, 1992.


Under the conditions of this experiment, the test item was found to cause blue to light blue staining of the treated skin.
No corrosion was observed at each of the measuring intervals.

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
Study period:
From April 25th to May 20th, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
July 31st, 1992
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 24th, 1987
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg into one eye
Duration of treatment / exposure:
No rinsing
Observation period (in vivo):
1, 24, 48 and 72 hours as well as 7, 14, 21 days after administration
Number of animals or in vitro replicates:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no observation at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible within 7 days. No corrosion was observed at any of the measuring intervals.
Other effects:
COLORATION: conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
MORTALITY/CLINICAL SIGNS: no mortality and no clinical signs were observed.
Interpretation of results:
other: Eye Dam. 1 (H318), according to the CLP Regulation No (EC) 1272/2008
Conclusions:
Blue staining of the sclera and conjunctivae by the test article was observed in all animals. Conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.
No corrosion was observed at any of the measuring intervals.
Executive summary:

The study procedures described in this report are based on the OECD Guideline 405 adopted February 24th, 1987.


Under the conditions of this experiment, the test item was found to cause blue staining of the sclera and conjunctivae.


Reversibility of any observed effect: changes fully reversible within 7 days.


No corrosion was observed at any of the measuring intervals..

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The study procedures described in this report are based on the OECD Guideline 404 adopted July 17th, 1992.


Under the conditions of this experiment, the test item was found to cause blue to light blue staining of the treated skin.
No corrosion was observed at each of the measuring intervals.


 


The study procedures described in this report are based on the OECD Guideline 405 adopted February 24th, 1987.


Under the conditions of this experiment, the test item was found to cause blue staining of the sclera and conjunctivae.


Conjunctival staining was reversible in two of three animals after 21 days, whereas scleral staining persisted until the end of the observation period.

Justification for classification or non-classification

Skin irritation


According to the CLP Regulation (EC) No. 1272/2008, Table: 3.2.2, Substances can be allocated in category 2 if the:


(1)  Mean score of ≥ 2,3 and ≤ 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 reactions; 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.


For the substance under investigation the scores for erythema and oedema are always below the treshold for classification set out in the CLP Regulation, therefore the substance is not classified as skin irritant. 


 


Eye irritation


According to the CLP Regulation (EC) No. 1272/2008, Table: 3.3.1, Substances can be allocated in category 1 if:


(a)  in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or


(b)  in at least 2 of 3 tested animals, a positive response of:


(i)  corneal opacity ≥ 3; and/or


(ii)  iritis > 1,5;


calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material.


For the substance under investigation, scleral staining persisted over 21 days. Therefore, the test substance is classified as Eye Dam. 1 according to the CLP Regulation (EC) No. 1272/2008.