Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Laboratory study in experienced laboratory.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

EC Number:

287-494-3

EC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

Cas Number:

85536-14-7

Molecular formula:

SO3C7H8-(CH2)n with n= 9-12

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs

Constituent 2

Reference substance name:

Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives (LABS)

IUPAC Name:

Benzenesulphonic acid, 4-C10-13-sec-alkyl derivatives (LABS)

Details on test material:

Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single treatment that was not washed out.

Observation period (in vivo):

1, 24, 48, and 72 hours and at 6 days after application.

Number of animals or in vitro replicates:

6 (3 male, 3 female)

Details on study design:

Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hrs and 6 days

Score:

46.9

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: moderately irritating

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritant / corrosive response data:

Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.

Any other information on results incl. tables

 

Results of Eye Irritation Study in Rabbits

Observation	Endpoint	Male 11655	Male 11715	Male 11771	Female 11798	Female 11804	Female 11838
1 hr	Cornea degree	1	1	2	2	2	1
1 hr	Cornea range	4	4	4	4	4	4
1 hr	Iris	1X	1X	1X	1X	1X	1X
1 hr	Conjunctiva redness	3N	3N	3N	2N	3N	3N
1 hr	Conjunctiva edema	1	1	1	1	2	2
1 hr	Conjunctiva - exsudation	3	3	3	3	3	3
24 hrs	Cornea -degree	1	1	2	2	3C	1
24 hrs	Cornea range	4	4	4	4	2	4
24 hrs	Iris	1*	1*	1*	1*	1*-	1*
24 hrs	Conjunctiva redness	3N	3N	3N	3N	3N S	3N
24 hrs	Conjunctiva edema	2	2	2	2	2	3
24 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
48 hrs	Cornea degree	1	1	2	2	3C	1
48 hrs	Cornea - range	4	4	4	4	2	4
48 hrs	Iris	1*	1*	1*	1*	1*-	1*
48 hrs	Conjunctiva redness	3N S	3N	3N S	3N S	3N S	3N S
48 hrs	Conjunctiva edema	2	1	1	1	2	3
48 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
72 hrs	Cornea degree	1	1	1	2	4C	1
72 hrs	Cornea - range	4	2	4	4	2	4
72 hrs	Iris	1X	1X	1*	1*	1*-	1*
72 hrs	Conjunctiva - redness	3N S	3N S	3N S	3N S	3N S	3N S
72 hrs	Conjunctiva edema	2	2	2	2	2	2
72 hrs	Conjunctiva - exsudation	2	2	2	2	2	2
6 days	Cornea degree	2	2	2	2	4C	2
6 days	Cornea -range	3	3	2	3	2	4
6 days	Iris	1X	1X	1*	1*	1*-	1*
6 days	Conjunctiva - redness	3N S L	3N L	3N L H	3N S L	3N S L	3N S L
6 days	Conjunctiva edema	2	2	2	2	2	2
6 days	Conjunctiva - exsudation	2	1	2	2	2	2

C Cornea cloudy

X Parts of the iris turned red

* - Iris turned red

- - Retarded iris reaction

N Necrosis and corrosion of the conjunctiva

S Secretion formation

L Lids became encrusted

H Holding head inclined

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Result: moderately irritating

Executive summary:

The eyes of six rabbits were treated with the test substance and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.