Adipohydrazide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Adipohydrazide

EC Number:

213-999-5

EC Name:

Adipohydrazide

Cas Number:

1071-93-8

Molecular formula:

C6H14N4O2

IUPAC Name:

hexanedihydrazide

Constituent 2

Reference substance name:

adipic acid dihydrazide

IUPAC Name:

adipic acid dihydrazide

Details on test material:

Appearance: White, odourless powder. Batch No.: SUIA 406Conditions of storage: In the refrigerator, in the dark, may be used under light. Stability in aqueous solution / suspension: Stable.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld.Number and sex: 3 females.Body weights (at the start and at the termination of the study): 1.9-2.4 and 2.1-2.6 kgHygiene: Optimal hygienic conditions.Room temperature: Average of 19.6 °C (continuous control and recording).Relative humidity: Average of 66.3 % (continuous control and recording).Light: Artificial light from 6 a.m. to 6 p.m.Cages: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Analysis of the feed for ingredients and contaminants is performed randomly by Altromin, D-32791 Lage, Germany.Hay-briquettes (supplied by SSNIFF, D-59494 Soest) are offered additionally as a dietary supplement.Water: Tap water from an automatic watering system, ad libitum.Environmental Enrichment: Aspen wood boards during acclimatisation and observation period. Exception: boards were withdrawn during the exposure.Acclimatisation: 5 days (1 animal) and 12 days (2 animals).Identification: Individual labelling with felt-tipped pen on an ear pinna and cage labels.Sacrifice of animals: The animals were killed by inhalation of 80 % CO2 + 20 % air.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

The weighed amounts of the individual doses were 60, 60 and 61 mg.

Duration of treatment / exposure:

The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance.The left eyes remained untreated and served as a control.

Observation period (in vivo):

Both eyes of the animals were examined within 24 hours before the instillation and approximately 1, 24, 48 and 72 hours p.a.

Number of animals or in vitro replicates:

3

Details on study design:

Prior to starting the eye irritation/corrosion study the pH-value of the test substance was determined. Firstly, the test substance was given to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72 hour observation period (no corrosive effect), the test substance was administered to the other two animals subsequently.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: each

Time point:

other: 24 hours before the instillation and ca. 1, 24, 48 and 72 hours p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

animal: each

Time point:

other: 24 hours before the instillation and ca. 1, 24, 48 and 72 hours p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: each

Time point:

other: 24 hours before the instillation and ca. 1, 24, 48 and 72 hours p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

animal: each

Time point:

other: 24 hours before the instillation and ca. 1, 24, 48 and 72 hours p.a.

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Other effects:

No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

The untreated eyes ("control eyes") were normal at each observation time. The eyes, treated with the test substance ("test eyes") were normal before the instillation and at each observation time.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Adipic acid dihydrazide is not irritating to eyes.

Executive summary:

The possible irritation by the test substance following a single application to the intact eyes of rabbits was determined applying the OECD and the EU-methods.

Results: Cornea, iris, conjunctiva and chemosis were not affected by the test substance.

Adipic acid dihydrazide is not irritating to eyes.