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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from the hydrolysis product of SOCl2 (HCl)
Adequacy of study:
key study
Study period:
Not specified; published in 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Sex, weight, and source of the animals as well as individual observations are not reported. Source and purity of test material are not reported. However, results following an OECD guideline show eye damage fully compatible with instillation of a strong acid; these results provide clear indication that the a.i. is likely corrosive and that no further animals should be tested for this endpoint.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Hydrogen chloride
EC Number:
231-595-7
EC Name:
Hydrogen chloride
Cas Number:
7647-01-0
IUPAC Name:
chloride
Details on test material:
Hydrochloric acid aqueous solution at 10% .
No further details specified.

Test animals / tissue source

Species:
other: Rabbit (Albino)
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not stated
- Age at study initiation: not stated
- Weight at study initiation: not stated
- Housing: not stated
- Diet (e.g. ad libitum): not stated
- Water (e.g. ad libitum): not stated
- Acclimation period: not stated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated


IN-LIFE DATES: not stated

Test system

Vehicle:
water
Controls:
other: untreated eye served as control. No control animals were used.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL aqueous solution
- Concentration (if solution): 10% in water

VEHICLE
No details specified.
Duration of treatment / exposure:
Single exposure in the lower conjunctival sac.
Observation period (in vivo):
96 hours
Number of animals or in vitro replicates:
6
Details on study design:
Examination time points: 4, 24, 48, 72 and 96 hours post-treatment.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: not specified

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: application of one drop fluorescein 2% before visual scoring of percentage corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 96 hrs
Score:
>= 1.9 - <= 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Scoring up to 96 hours post-treatment
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 96 hrs popst treatment
Score:
>= 1 - <= 2.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scoring up to 96 hrs post treatment
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 96 hours post treatment
Score:
>= 1 - <= 1.7
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: scoring up to 96 hrs post treatment
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 96 hrs post treatment
Score:
>= 1.3 - <= 3.3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scoring up to 96 hrs post treatment
Irritation parameter:
cornea opacity score
Remarks:
damage
Basis:
mean
Time point:
other: 4, 24, 48, 72 and 96 hours post treatment
Score:
>= 15 - <= 59
Max. score:
100
Reversibility:
not fully reversible within: 96 hours
Remarks on result:
other: scoring up to 96 hrs post treatment
Irritant / corrosive response data:
Results are reported in "Remarks on results including tables and figures".
Other effects:
Not stated.

Any other information on results incl. tables

Results of eye irritation study

Time after application (hrs)

4

24

48

72

96

Mean score of conjunctivitis(maximum 3)

1.9

2.8

3.0

3.0

2.9

Mean score of chemosis(maximum 4)

1.0

1.7

2.3

2.3

2.0

Mean score of iritis(maximum 2)

1.0

1.3

1.7

1.7

1.7

Mean score of corneal opacity(maximum 4)

1.3

2.0

2.7

3.3

3.0

Mean score of corneal damage(maximum 100%)

15

59

49

42

28

Summary of results and discussion:

HCl applied as an aqueous solution at a percentage of 10% was classified as “Risk of serious damage to eyes” according to the 83/467/criteria (mean over 24/48/72 hrs of iritis >1.5).

Applicant's summary and conclusion

Interpretation of results:
other: Risk of serious damage to eyes
Remarks:
Criteria used for interpretation of results: other: 83/467/EEC criteria (mean over 24/48/72 hrs of iritis >1.5)
Conclusions:
HCl applied as an aqueous solution at a percentage of 10% was classified as “Risk of serious damage to eyes” according to the 83/467/EEC criteria (mean over 24/48/72 hrs of iritis >1.5).