Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
EC Number:
916-916-7
Molecular formula:
not available
IUPAC Name:
Reaction mass of lithium sodium 5-amino-3-{[4-(2-{4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)diazenyl]-2-sulfophenyl}vinyl)-3-sulfophenyl]diazenyl}-4-hydroxynaphthalene-2,7-disulfonate 2,2'-(methylimino)diethanol (1:1) and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[6-amino-4-hydroxynaphthalene-2-sulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol and 3,3'-[vinylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, lithium sodium salt, compound with 2,2'-(methylimino)diethanol
Test material form:
other: liquid
Details on test material:
no details on content in the report

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
- Humidity: 50 %

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
1 second
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour - 21 days
Score:
ca. 0
Max. score:
4
Irritant / corrosive response data:
No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits (score 0).
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

Eye irritation test was performed according to OECD TG 405 and GLP: 100 µl of the test compound was instilled into the conjunctival sac of one eye of each of 3 rabbits after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second . The treated eye was washed out with physiological saline 24 hours after instillation of the test compound. The other eye remained untreated and served as control . Eye irritation was scored according to Draize during the observation period of 21 days. No reactions in conjunctivae, cornea or iris of the eyes were observed in none of the 3 rabbits.(Score 0 ). Therefore, the test compound is evaluated as not irritating to the eyes of rabbits. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.