Reaction mass of tridecanal and 2-methyldodecanal and pentadecanal and 2-methyltetradecanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 4 MAR 1985 to 11 MAR 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: initial body weights of the test animals differ slightly to much

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

112-44-7 + 19009-56-4

IUPAC Name:

112-44-7 + 19009-56-4

Constituent 2

Reference substance name:

n-Undecanal + 2-methyldecan-1-al

IUPAC Name:

n-Undecanal + 2-methyldecan-1-al

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.24 to 2.87 kg
- Housing: suspended metal cages, individually
- Diet: standard laboratory diet (Rabbit Diet, A .W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 45-61
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

The treated and control eyes the animals remained unwashed throughout the observation period.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: basically according to guideline OECD 405

TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler)

Reeding times: 1, 24, 48 and 72 hours following treatment (if irritation persisted at the 72 h observation additional readings were made at 7, 14 and 21 days)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

of all animals; individual scores per animal: 1/0.33/1

Time point:

other: 24-48-72 h

Score:

0.78

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all animals; individual scores per animal: 1/0/1

Time point:

other: 24-48-72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Observations at reading times (scores are given for animal#1/#2/#3) :
- 1h: diffuse crimson red colouration of the conjunctivae accompanied by slight swelling in all three animals (conjuctivae redness 2/2/2; chemosis 2/2/2; discharge 2/2/2; all other scores in all animals are 0)
- 24 h: reduction in the level of reaction in all three animals (conjuctivae redness 1/1/1; chemosis 1/0/1; discharge 0/0/0; all other scores in all animals are 0)
- 48 h: the reactions had already ameliorated completely in one rabbit (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 72 h: (conjuctivae redness 1/0/1; chemosis 1/0/1; all other scores in all animals are 0)
- 7 days: the remaining two rabbits are fully recovered (all scores are 0)

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions tested the test item is not irritating to eyes of rabbits.

Executive summary:

Irritation of the eye was tested in 3 New Zealand white rabbits according to guideline OECD 405. 0.1 mL of test item (purity: not stated, undiluted, not washed out) were instilled into the lower conjunctival sac of the right eye of each rabbit. At relevant reading times (24, 48 and 72 h after test material instillation) slight irritating effects on the conjunctiva (redness (mean score: 0.78; indivial scores per animal: 1/0.33/1)) and chemosis (mean score: 0.67; individual ) were observed in all animals. All effects were fully reversible within 7 days and no effects on the cornea or iris were observed, thus the test item is not irritating to the eye.

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity.