Registration Dossier

Administrative data

Description of key information

The substance was not irritating to the skin but highly irritating to the eyes.

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:
December 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP
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
Principles of method if other than guideline:
A single semi-occlusive application of 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene to intact rabbit skin for 4 hours was conducted.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
4 days
Number of animals:
3 animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
none
Interpretation of results:
GHS criteria not met
Conclusions:
Because the test substance did not induce skin irritation, no classification is needed.
Executive summary:

In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be not irritating to rabbit skin. No relevant systemic intolerance reactions were observed.

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:
December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP
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
Principles of method if other than guideline:
The test substance was instilled into the eye of one rabbit.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
other: no vehicle used
Controls:
no
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
After placing the test substance into the lower everted lid of one eye, eyelids were gently held together for one second before releasing.
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
1 animal.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Other effects:
Due to the severity of the effects the animal was killed 24 hours after instillation for humane reasons. Corneal opcity covered nearly the whole area. Blanching of the eyelids and a copious discharge were seen.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Because of the premature killing of the animal no judgement can be made on reversibility. The test substance was highly irritating and should be classified as 'risk of serious damage to eyes'.
Executive summary:

In an eye irritation test according to OECD 405 the test substance led to highly irritating effects in one rabbit (redness grade 2, chemosis grade 4, coneal opacity grade 4 with discharge). This rabbit was killed 24 h after treatment for animal welfare reasons and no further animals were treated. Thus, the test substance should be regarded as severely damaging the eyes of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be not irritating to rabbit skin. No relevant systemic intolerance reactions were observed.

In an eye irritation test according to OECD 405 the test substance led to highly irritating effects in one rabbit (redness grade 2, chemosis grade 4, corneal opacity grade 4 with discharge). This rabbit was killed 24 h after treatment for animal welfare reasons and no further animals were treated. Thus, the test substance should be regarded as severely damaging the eyes of rabbits.

No data are available for respiratory tract irritation. Inhalation of the gaseous substance is unlikely since the vapour pressure of the substance is very low. In case of aerosol contact an irritating potential to the respiratory tract can be assumed, since the substance is classified as severe eye irritant.


Justification for classification or non-classification

No effects for skin irritation were observed. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Damage 1 ( H318: Causes serious eye damage) is justified based on the study results of the eye irritation study