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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:
11 Mar 2003 - 16 Mar 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium mercaptoacetate
EC Number:
226-540-9
EC Name:
Ammonium mercaptoacetate
Cas Number:
5421-46-5
Molecular formula:
C2H4O2S.H3N
IUPAC Name:
ammonium 2-sulfanylacetate
Details on test material:
- Name of test material (as cited in study report): Ammonium thioglycolate 71%
- Physical state: colourless liquid
- Analytical purity: 71.5%
- Impurities (identity and concentrations): Iron < 0.1 ppm
- Purity test date: 14.02.2003
- Lot/batch No.: 4676
- Storage condition of test material: at room temperature and under nitrogen gas
- Other: Source: Bruno Bock Chemische Fabrik GmbH & Co KG

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation:  2-4 months
- Weight at study initiation: 2.7+/-0.2 kg
- Housing: individually in polystyrene cage (48.2 x 58 x 36.5 cm)
- Diet (e.g. ad libitum): 110 pelleted diet (SAFE, Villemoisson, Epinay sur Orge, France) ad  libitum
- Water (e.g. ad libitum): filtered drinking water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 71.5% active substance
Duration of treatment / exposure:
continuous
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

(For details on results refer to attached background material)

Very slight to moderate conjunctival reactions, including a very slight or slight chemosis (grade 1 or 2), a very slight to moderate redness of the conjunctiva (grades 1 to 3) and a clear to whitish purulent discharge, were observed in all animals, from day 1 up to day 3. No other ocular reactions were noted during the study.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.7 and 0.7 for chemosis, 0.7, 1.0 and 1.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item ammonium thioglycolate 71% is slightly irritant when administrated by ocular route to rabbits.
The criteria for classification as an eye irritant are not met.