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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
419-800-1
EC Name:
-
Cas Number:
112101-81-2
Molecular formula:
C10H16N2O3S
IUPAC Name:
(R)-5-(2-Aminopropyl)-2-methoxybenzenesulfonamide
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:NZW/Kbl(BR)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd.
- Age at study initiation: Sixteen to nineteen weeks old
- Weight at study initiation: 3.16 to 3.57 Kg
- Housing: Single floor pens accomodating 1 rabbit with a minium floor area of 0.6 sq m.
- Diet (e.g. ad libitum): SQC standard rabbit diet (pelleted) was freely available at all times.
- Water (e.g. ad libitum): Mains water was provided ad libitum.
- Acclimation period: At least 1 month.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22°C
- Humidity (%): 40 to 80% RH
- Air changes (per hr): At least 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Vehicle:
water
Remarks:
Dispersed in distilled water
Controls:
not required
Amount / concentration applied:
The test article was dispersed in distilled water and the pH of the 50% preparation was confirmed not to exceed 11.5 or to be less than 2 before dosing commenced. The test article was administered as a known weight (67 mg) with a compacted volume of 0.1 mL. Doses were expressed in terms of test article received and all doses were used on the day or preparation.
Duration of treatment / exposure:
A singular ocular instillation
Observation period (in vivo):
Not less than 3 days
Number of animals or in vitro replicates:
3 rabbits (one sentinel followed by a further two exposures)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not performed

SCORING SYSTEM:
Standard as per OECD 405 guideline. The 'initial sting' response was assessed and recorded immediately after instillation of the test article. Treated animals were inspected for indications of distress or unacceptable ocular changes frequently during Day 1 (the day of dosing) and at least daily until completion of the observation period. Ocular changes were assessed and recorded immediately after treatment, one half hour, one and four hours after treatment on Day 1, and 24, 48 and 72 hours after treatment.

TOOL USED TO ASSESS SCORE: The treated eyes were examined visually or with the aid of a pencil-beam torch, biomicroscope or other device to illuminate or magnify the eye during examination. At examinations carried out 24 hours after treatment the cornea was subject to application of 2% aqueous fluorescein solution followed by irrigation with water for irrigation and illumination by an ultraviolet source. This facilitated detection of damage to the corneal epithelium as indicated by absorption of the fluorescing dye into the epithelium or stroma. The application of fluorescein was repeated in two rabbits 48 hours after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Instillation of the substance caused practically no initial sting response or a slight initial sting response. All rabbits developed a crimson-red appearance of the conjunctivae shortly after treatment. This was associated with slight chemosis in two rabbits and with a slight ocular discharge in one of the same animals. No conjunctival reactions of greater intensity developed later in the study but resolution of conjunctival irritation remained incomplete until three days after treatment.

The cornea of one rabbit showed an area (approximately 2 x 5 mm) of slight opacity that was also permeable to applied fluorescein on the day after ocular instillation of the test article. This corneal change resolved within two days of treatment. The iris remained overtly unaffected by the test substance.
Other effects:
No observations indicative of systemic toxicity or ill health were noted for any rabbits during the course of the study.

Any other information on results incl. tables

Group mean values for ocular reactions

Time of observation

Ocular reaction

Corneal opacity

Iris

Conjunctival redness

Chemosis

1 hour

0

0

1

0

4 hour

0

0

1.3

0.7

24 hour

0.3

0

0.7

0.3

48 hour

0

0

0.7

0.3

72 hour

0

0

0

0

Mean of 24, 48, and 72 hour scores

0.1

0

0.4

0.2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Single instillation of the test substance to the conjunctival sac of three rabbits caused reversible changes of the conjunctivae in all animals and a transient and minor opacity of the cornea of one animal. However, the effects observed did not merit classification under UN GHS or the CLP Regulation (EC No. 1272/2008).