Isooctyl mercaptoacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29-Sep-1993 to 07-Jan-1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isooctyl mercaptoacetate

EC Number:

246-613-9

EC Name:

Isooctyl mercaptoacetate

Cas Number:

25103-09-7

Molecular formula:

C10H20O2S

IUPAC Name:

2-methylheptyl 2-sulfanylacetate

Details on test material:

Identification: Isooctyl thioglycolate (IOTG)
CAS no. 25103-09-7
Source: Elf Aquitaine production
Batch: TA 2511
Purity: 99.05 % (w/w)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 3.0 +/- 0.3 kg
- Housing: individually in polystyrene cage
- Diet (ad libitum): 112 C pelleted diet (UAR)
- Water (ad libitum): filtered tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 20°C
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

A single dose of 0.1 mL of the undiluted test item was instilled into the conjunctival sac of the left eye of 3 male New Zealand rabbits. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration.  The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated.

Results and discussion

In vivo

Results

Irritation parameter:

chemosis score

Remarks:

Chemosis and Redness

Basis:

mean

Time point:

24 h

Score:

ca. 0

Max. score:

0.3

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under our experimental conditions, the test substance iOTG was considered as non-irritant when administered by ocular route in rabbits.

Executive summary:

0.1 mL undiluted IOTG was instilled into the conjunctival sac of the left eye of 3 male rabbits following OECD test guideline 405. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated. Slight chemosis and/or redness of the conjunctiva were noted within 24 hours post-treatment. No ocular reactions were observed on days 3 and 4. No iris lesions and no corneal opacity were noted during the study. The mean scores over 24, 48 and 72 hours for individual animals were 0.0, 0.0 and 0.0 for chemosis; 0.3, 0.0 and 0.0 for redness; 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.