Bis(2-ethylhexyl) azelate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

06 Dec - 13 Dec 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP conditions with acceptable restrictions (purity of test substance not given, no reading at 72 hours (full reversibility at 48 h))

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

yes

Remarks:

purity of test substance not given, no reading at 72 hours (full reversibility at 48 h)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

69275-01-0

Cas Number:

69275-01-0

IUPAC Name:

69275-01-0

Details on test material:

- Name of test material (as cited in study report): Di-(2-octyl-dodecyl)-sebacate
- Physical state: colorless liquid
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrusse Chbb: HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: 2360 g
- Housing: one animal per cage in cages of Fa. Heinkel, 7343 Kuchen, Germany
- Diet: Altromin diet 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 month

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

48 hours
reading time points at 1, 6, 24 and 48 hours

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM: Draize Scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean over 24 and 48 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean over 24 and 48 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean over 24 and 48 hours

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean over 24 and 48 hours

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

From 1 hour up to 6 hours after application one animal showed slight, the three others distinct redness of the conjunctiva. 24 hours after application 2 animals were without any reactions, the other two were without effects 48 hours after application.

Other effects:

One animal showed slight, the other three strong exsudation from 1 hour up to 6 hours after application. 2 animals did not show exsudation any more 24 hours after application. For the other two animals exsudation was only slight at 24 hours and completely gone after 48 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified