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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: the study was performed according to OECD-/EU-testing guidelines, but not under GLP; therefore the study was considered to have Klimisch 2

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Dir. 79/831/EEC, Annex V
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Valeroniitrile
IUPAC Name:
Valeroniitrile
Details on test material:
- Physical state: Colourless liquid
- Density: 0.804
- Quantity of test sample: ca. 200 g
- Date of receipt: 7 February 1983
- pH-value: 9.6 (measured during test)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: several accredited breeders
- Weight at study initiation: ca. 2.5 kg (+/- 200 g)
- Housing: individual housing on polystyrene cages with perforated polystyrene floor
- Diet (e.g. ad libitum): 150 g per rabbit & day of complete maintenance food (granulés Lapin Entretien "112" UAR, 91360 Villemoisson, Orge)
- Water (e.g. ad libitum): softened and filtered tap water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (+/- 3°C)
- Humidity (%): 30-70%
- Air changes (per hr): 12 times per hour (pre-filtered air 15 µm)
- Photoperiod (hrs dark / hrs light): artificial light for 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of test item as such was instilled in the eye conjunctival sac. Eyes were not rinsed at the end of treatment.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Observation 1 hour, 24 hours, 48 hours, 72 hours, 96 hours and 7 days after removal of patch
Number of animals or in vitro replicates:
6 animals
Details on study design:
Each rabbit was immobilized in a plastic restraining box (Iffa Crédo). The test substance was introduced into the inferior conjunctival sac of the right eye. The left eye served as control. The upper and lower eyelids were held together for several seconds to avoid any loss of test substance.
The animals were restrained for 4 hours, and then replaced in individual cages.
The eyes of 3 rabbits were washed out 4 seconds after instillation, care being taken not to cause injury, and on 3 other animals 30 seconds after the application of the test substance. About 50 ml of the rinsing solution at about 20°C was administered using a plastic jet at moderate pressure.
The control eye was washed out under the same conditions as the treated one.
The excess of liquid was immediately wiped away with a Codex hydrophilic gauze pad.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Mean Index of Ocular Irritation (M.O.I.)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24h
Score:
5.17
Max. score:
110
Reversibility:
fully reversible within: 96h
Irritation parameter:
other: Mean Index of Ocular Irritation (M.O.I.)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 48h
Score:
2.67
Max. score:
110
Reversibility:
fully reversible within: 96h
Irritation parameter:
other: Mean Index of Ocular Irritation (M.O.I.)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 72h
Score:
0.83
Max. score:
110
Reversibility:
fully reversible within: 96h
Irritation parameter:
other: Mean Index of Ocular Irritation (M.O.I.)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 96h
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 96h
Irritant / corrosive response data:
The substance was found to be slightly irritiating, but not corrosive to rabbit eyes.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was classified as non-irritant to eyes according to EU GHS-criteria.
Executive summary:

The study was performed 1983, following the EU-testing guideline B.5 as non-GLP-study. 6 New Zealand White rabbits were used in this study. 0.1 ml test item was instilled in the conjunctival sac. Obervations were done applied after one hour, 24, 48 and 72 hours and after 4 and 7 days. The substance was found to be slightly irritating to rabbit eyes.

Valeronitrile is not classified as eye irritant, based on these results.