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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 21 to 24 September 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Study conducted prior to the adoption of the most recent version of this Guideline
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl mercaptoacetate
EC Number:
231-626-4
EC Name:
2-ethylhexyl mercaptoacetate
Cas Number:
7659-86-1
Molecular formula:
C10H20O2S
IUPAC Name:
2-ethylhexyl 2-sulfanylacetate
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexyl thioglycolate
- Physical state: colourless liquid
- Expiration date of the lot/batch: January 1994
- Storage condition of test material: at room temperature, away from light

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, France
- Sex: male
- Age at study initiation: not reported
- Weight on the day of treatment: 3.1 +/- 0.5 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 or 48.2 x 58 x 36.5 cm)
- Diet: 112 C pelleted diet ad libitum
- Water: filtered by Millipore membrane ad libitum
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 21 September 1993 To: 24 September 1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL was instilled into the conjunctival sac of the left eye of rabbits
Duration of treatment / exposure:
The eyes were not rinsed after administration of the test substance
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM: treated eyes were scored for conjunctival lesions and discharge, iris lesions and corneal lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 +48 + 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 +48 + 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 +48 + 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 +48 + 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No ocular reactions were observed during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
2-ethylhexyl mercaptoacetate is not irritating to eyes.
Executive summary:

0.1 mL undiluted EHTG 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. No ocular reactions were observed during the study; EHTG was not irritating to the rabbit eye under the conditions of this study.