5-Benzofuranacetic acid, 2,3-dihydro-, methyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 04 February 2002 to 27 February 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study without detailed documentations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

dated February 24th, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

dated December 29th, 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ADHBFA-Me

IUPAC Name:

ADHBFA-Me

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - 40260 Linxe)
- Age at study initiation: no data
- Weight at study initiation: 2.17-2.40 kg
- Housing: individual boxes installed in conventional air conditioned animal husbanding
- Diet: no data
- Water: no data
- Acclimation period: 13-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 39-48
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL instilled into one eye of each rabbit

Duration of treatment / exposure:

No data

Observation period (in vivo):

1 hour after instillation and 24, 48 and 72 hours later. In case of persistent reactions, additional observations are carried out from Day 4 to Day 21.

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: E.E.C. regulation compliant

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: very slight redness in 2 animals only 1 hour after instillation of the test material and a lachrymation in the three animals only at the 1 hour reading time point.
The MaximumOcular Irritation Index determined in compliance with the "Journal Officiel de la Rébublique Française dated July 10th, 1992" was equal to 6.0 (slightly irritant).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test material is not irritating to the rabbit eye.

Executive summary:

This GLP-compliant study was performed to assess the potential of the test material to induce eye irritation in vivo, according to OECD Guideline 405 (dated February 24th, 1987) and EU method B.5 of the E.E.C. directive n° 92/69 (dated December 29th, 1992)

 

Material and methods

0.1 mL of the test material were instilled as supplied, into one eye of each of the 3 rabbit females, the other eye untreated serving as control. Ocular examinations were performed on both right and left eyes 1 hour and then 24, 48 and 72 hours after instillation (in case of persistent reactions, additional observations would have been carried out until day 21).

 

Results

The ocular reactions observed during the study remained slight and only recorded at the conjunctivae level: very slight redness in 2 animals only 1 hour after instillation of the test material and a lachrymation in the three animals only at the 1 hour reading time point. The individual mean scores (24, 48 and 72 hours) for cornea, iris, conjunctivae and chemosis were all as follows: 0, 0 and 0.

 

Conclusion

Under the experimental conditions of this study, the test material is no classified as irritating to eyes according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.