2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate

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:

01 Jul - 08 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions (analytical purity not reported)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1984

Deviations:

yes

Remarks:

analytical purity not reported; single application without washing.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

97281-24-8

Cas Number:

97281-24-8

IUPAC Name:

97281-24-8

Details on test material:

- Name of test material (as cited in study report): only trade name given- Physical state: liquid - Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: Chbb: HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Thomae, Biberach, Germany- Weight at study initiation: 2.7 kg- Housing: individual housing- Diet: Altromin-Haltungsdiät, ad libitum- Water: tap water, ad libitum- Acclimation period: at least 7 daysENVIRONMENTAL 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

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

3 daysReading time points: 1, 6, 24, 48, and 72 h

Number of animals or in vitro replicates:

4 males

Details on study design:

SCORING SYSTEM: Draize scoring systemTOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Slight conjuctival reactions were observed between 1-6 hours after treatment. They consisted in redness (4/4 animals within the first hour after treatment, 3/4 within 6 hours after treatment) and exudation (4/4 animals within the first hour after treatment). However, these reactions were fully reversible within 24 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

CLP: not classifiedDSD: not classified