Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Mar - 18 Mar 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study with acceptable restrictions, in some cases the animals had already been used in earlier studies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

in some cases the animals had already been used in earlier studies.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

in some cases the animals had already been used in earlier studies.

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts

EC Number:

939-603-7

Cas Number:

1471316-72-9

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

Benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts

Details on test material:

- Name of test material (as cited in study report): benzenesulfonic acid, di-C10-14-alkyl derivs., calcium salts
- Physical state: liquid, brown
- Analytical purity: 100%
- Lot/batch No.: 06-6923
- Expiration date of the lot/batch: 2008-11-11
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

other: Crl:KBL(NZW)BR

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals (females)
- Weight at study initiation: 2300 - 2600 g
- Housing: individual housing in Metall/Noryl (EBECO) cages, excrement trays below the cages contained low dust wood granulate bedding.
- Diet: standard diet Ssniff (Spezialdiäten GmbH, Soest, Germany), approximately 100 g/animal/day. Hay or hay pellets were offered additionally (hay, irradiated, Harlan Winkelmann GmbH, Borchen Germany; hay pellets, Ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was rinsed
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Cornea/Iris: No effects on cornea or iris were observed during the study period in any animal.
Conjunctivae: At the 1 and 24 h reading time point all animals showed moderate conjunctivae redness. After 48 h mild redness was apparent in all animals, still persistent in 2/3 animals after 72 h. All conjunctivae redness was fully reversible within 72 h and 7 days, respectively.
Chemosis: 3/3 animals showed mild swelling after 24 h which was fully reversible in 2/3 animals after 48 h. In 1/3 animals chemosis was persistent up to 72 h and fully reversible after 7 days.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

 Table 1. Results of eye irritation study. 

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	2	0	0	0
	24	2	1	0	0
	48	1	0	0	0
	72	1	0	0	0
	168	0	0	0	0
	average	1.3	0.3	0.0	0.0
2	1	2	0	0	0
	24	2	1	0	0
	48	1	1	0	0
	72	1	1	0	0
	168	0	0	0	0
	average	1.3	1.0	0.0	0.0
3	1	2	0	0	0
	24	2	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	average	1.0	0.3	0.0	0.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
mean over	1	2.00	0.00	0.00	0.00
	24	2.00	1.00	0.00	0.00
	48	1.00	0.33	0.00	0.00
	72	0.67	0.33	0.00	0.00
	24+48+72	1.22	0.56	0.00	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

The study objective was to determine the irritant effects of the target substance on eyes of albino rabbits (strain Crl:KBL(NZW)BR) (Gmelin, 2008). The study was conducted according to OECD TG 405 and GLP and is assigned as Klimish 1. 0.1 mL of the pure liquid test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The eye was rinsed approximately 24 hours following instillation. There was no severe irritation observed in the first animal, therefore two further rabbits were treated in the same manner. Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application. Irritation indices were observed after 72 h, therefore the animals were monitored on day 7, 14 and 21 after application until the changes had completely subsided. The degree of ocular lesions was recorded as specified by Draize. The body weight of each animal was recorded at the beginning of the study. If clinical findings other than eye irritations occur they were recorded daily.

The mean scores at 24 -h, 48 -h, and 72 -h reading time points were 0.0 for corneal opacity and iritis for three animals. Redness sconjunctivae scores were 1.3, 1.3 and 1.0 and chemosis conjunctivae scores were 0.3, 1.0 and 0.3 for animal 1, 2, and 3, respectively. All irritation reactions were fully reversible within 7 days. There were no systemic intolerance reactions. According to the classification criteria (CLP/GHS), the substance is not irritating to eyes.