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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
Justification for type of information:
Justification for not submitting the in vitro study.
The new legal requirements (21 June 2016) require an in vitro eye irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 T/y tonnage band. Therefore there is no need to repeat the study using the alternative test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butylbenzenesulphonamide
EC Number:
222-823-6
EC Name:
N-butylbenzenesulphonamide
Cas Number:
3622-84-2
Molecular formula:
C10H15NO2S
IUPAC Name:
N-butylbenzenesulfonamide
Details on test material:
- Name of test material (as cited in study report):N-n-butylbenzenesulphonamide (Proviplast 024) BBSA
- Physical state: clear liquid
- Analytical purity: 99.94%
- Lot/batch No.: 200911030035
- Storage condition of test material: stored at dry cool and well ventilated area in the utility room
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: From the animal house facility of IIBAT, Padappai-601 301, Kancheepuram district, Tamil Nadu, India
- Weight at study initiation: 2.136-2.591 kg
- Housing: animals were housed individually in standard rabbit cages
- Diet (e.g. ad libitum): ad libitum standard pellet feed supplied by M/s Amrut Laboratory Animal Feed, Pune -30
- Water (e.g. ad libitum): ad libitum UV treated water
- Acclimation period:5 days prior to the experiment in the test room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3-21.7°C
- Humidity (%): 53-66%
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): a volume of 0.1 ml test substance was instilled as such into the conjunctival sac of the rabbits
Duration of treatment / exposure:
the eyes of the test animals were washed after 24h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3 females (nulliparous and non-pregnant
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 24h after instillation


SCORING SYSTEM: Draize 1959 scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: all 3
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritant / corrosive response data:
The mean score of ocular lesion is 0 +/- 0.0 at 1, 24, 48 and 72h. Non of the animals showed any lesions throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide (Proviplast 024) was considered as Non-Irritant (N) to the eyes of New Zealand white rabbits.
Executive summary:

An acute eye irritation/corrosion study was conducted with N-n-butylbenzenesulphonamide in New Zealand white rabbits. The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide was considered as Non-Irritant to the eyes of New Zealand white rabbits.

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