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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation; 50 mg instead of 100 mg test substance instilled.) Study sufficient for evaluation of this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
application volume
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50mg or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalonitrile
EC Number:
202-044-8
EC Name:
Phthalonitrile
Cas Number:
91-15-6
Molecular formula:
C8H4N2
IUPAC Name:
benzene-1,2-dicarbonitrile
Details on test material:
- Name of test material (as cited in study report): phthalonitrile
- Analytical purity: 99.96 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.27 - 2.38 kg

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: approx. 50 mg of talcum into the other eye
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Reversibility:
other: no effect
Remarks on result:
other: Substance residues were observed on the day of application. Effects observed were equivalent to the effects of the negative control (talcum)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Reversibility:
other: no effect
Remarks on result:
other: Effects observed were less or equivalent to the effects of the negative control (talcum)

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (limited documentation, reduced application volume). The study is however sufficient for evaluation of this endpoint. Irritation effects were not observed after 24 and 48 h. Equivalent effects to the talcum-treated eyes were observed on the day of application.

Conclusions

O-phthalonitrile is considered as non-irritating to the eye.