Reaction mass of 2-methyldecan-1-al and undecanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

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 too much

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

n-undecanal

IUPAC Name:

n-undecanal

Constituent 2

Reference substance name:

2-methyl decanal

IUPAC Name:

2-methyl decanal

Constituent 3

Reference substance name:

n/i-undecanal

IUPAC Name:

n/i-undecanal

Details on test material:

- Name of test material (as cited in study report): n/i-undecanal
- Substance type: colourless
- Physical state: liquid
- Stability under test conditions: room temperature

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:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

: individual scores (mean) 1/0.33/0

Time point:

other: 24-48-72 h

Score:

0.78

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

: individual scores (mean) 1/0/1

Time point:

other: 24-48-72 h

Score:

0.67

Max. score:

1

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)
- 7 days: the remaining two rabbits are fully recovered (all scores are 0)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP Regulation

Conclusions:

Under the conditions tested the test item was 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. Slight irritating effects on the conjunctiva (redness; mean score: 0.78) and chemosis (mean score: 0.67) 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 (Ruhrchemie AG/Safepharm, 1985).

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition or purity. Pronounced conjunctival effects seen at 1 hour after treatment are not relevant for classification according to regulation EC/1272/2008. The test substance was therefore not irritating.

This result can be transferred to the registered n-/iso-undecanal. The proportions of n- or iso-undecanal of the test material is not reported. Read Across is therefore considered. Refer to the discussion field of the endpoint summary for detailed justification of read across.