N-ethyl-o(or p)-toluenesulphonamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 August 1985 - 22 August 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Adopted 12 May 1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-ethyl-o(or p)-toluenesulphonamide

EC Number:

232-465-2

EC Name:

N-ethyl-o(or p)-toluenesulphonamide

Cas Number:

8047-99-2

Molecular formula:

C9H13NO2S

IUPAC Name:

N-ethyl-4-methylbenzene-1-sulfonamide

Test material form:

liquid: viscous

Remarks:

Colour: light yellow

Details on test material:

Ketjenflex 8 (NETSA)
Chemical name in report: N-ethyl-o/p-toluenesulfonamide (or N-substituted toluene sulphonamide)
Description: light yellow viscous liquid
Purity 100% (or 90%)

Test substance storage: at room temperature in the dark
Stability under storage conditions: stable

Specific details on test material used for the study:

- Chemical name: N-substituted toulene sulphonamide
- Trade name/code: Ketjenflex 8
- Impurity: Approx. 10% o/p toulene sulfonamide
- Specific gravity: Approx. 1200 kg/m3 (at 25 ̊ C)
- Solubility: Organic solvents except petroleum hydrocarbons
- Flash point: 224 ̊ C
- Boiling point: > 340 ̊ C
- Vapour pressure: < 1mm Hg at 150 ̊ C
- Appearance: Light yellow, viscous liquid
- Storage: At ambient temperature in the dark
- Stability: Practically unlimited

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Obtained from The Broekman Institute, Someren,The Netherlands.
- Age at study initiation: Approximately 15 weeks old
- Weight at study initiation: 3378, 3165 and 3044 g
- Housing : In metal cages with perforated floors (RUCO, Valkenswaard).
- Diet (e.g. ad libitum): They were fed standard laboratory animal diet (100 g per day), obtained from Hope Farms, woerden (LK-01, pellet diameter 4mm)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: Quarantine period was 7 days followed by an acclimation period of approximately 2.5 months

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): Relative humidity 60-70
- Photoperiod (hrs dark / hrs light): The artificial light sequence was 12 hours light, 12 hours dark.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml of the test substance

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

Prior to dose administration, both eyes of the animals were inspected in order to detect any eye defect. Immediately after instillation of the test substance, the animals were observed and abnormalities were recorded. In addition, the eyes were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Grading of ocular lesions based on OECD 405 (1981)

TOOL USED TO ASSESS SCORE: fluorescein treatment
- a solution of 2% fluorescein in water (pH adjusted to 7.0) was applied to both eyes of each animal to examine quantitatively the potential for corneal injury

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Remarks:

swelling

Basis:

animal #1

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Results 8

Irritation parameter:

chemosis score

Remarks:

Redness

Basis:

animal #2

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

Mean Value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 11

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

Mean value

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Irritant / corrosive response data:

One hour after instillation of the test substance swelling of the conjunctivae above normal was observed in all three animals. At the same time conjunctival redness was scored as grade 2 for two animals and grade 1 for the remaining animal. These signs were reversible since by the following day swelling had completely disappeared in all animals and redness was decreased to grade 1 in the remaining animal. 48 hours after instillations no more abnormal conjunctival redness or swelling was observed. No effects of the cornea and iris were observed in any of the animals. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Conclusions:

Under the conditions of this test, no effects of the cornea and iris were observed in any of the animals.

Executive summary:

To investigate the potential eye irritating effects of Ketjenflex 8, a study was conducted according to OECD 405 (adopted in 1981). 0.1 ml of the test substance was applied by instillation into one eye of, in total three female New Zealand White rabbits. No effects of the cornea and iris were observed in any of the animals. One hour after instillation moderate redness and mild was temporarily observed, however effects were reversible after 24 to 48 hours. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any epithelial damage in any of the animals. Based on these results, it can be concluded that Ketjenflex 8 does not need to be classified as an eye irritant according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP).