Benzene, bis(1-methylethyl)-, sulfonated, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01/12/2012-15/01/2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted at a GLP accredited laboratory to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium diisopropylbenzenesulphonate

EC Number:

248-984-2

EC Name:

Sodium diisopropylbenzenesulphonate

Cas Number:

28348-54-1

Molecular formula:

C12H18O3S.Na

IUPAC Name:

sodium diisopropylbenzenesulfonate

Test material form:

other: liquid

Details on test material:

Brown liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Millbrook
- Age at study initiation: 28 weeks
- Weight at study initiation: 3.8-4.2kg
- Housing:Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): All animals had access to PMI Certified Hi-Fiber Rabbit Diet #5325.
- Water (e.g. ad libitum): the tap water was available as libitim to each ainmal via an automatic watering device.
- Acclimation period: A min 7 days prior to dosing their housing were acclimated.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21 °C
- Humidity (%): 38-64
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eyes were used as control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Once

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

3

Details on study design:

Prior to dosing, the eyes were anesthetized using 2 drops of Tetracaine. Eltesol SDIBP 35/B was initially installed into the right eye of one male rabbit. The left eye was untreated. Following to one hour scores of the first animal, two additional animals were dosed. Scoring was done according to method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 2 and 3

Time point:

other: 1 and 24h

Score:

0 - <= 1

Max. score:

3

Reversibility:

fully reversible within: 48h

Remarks on result:

other: mild opacity

Results 2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: one hour post dose

Score:

0 - < 1

Max. score:

1

Reversibility:

fully reversible within: 24h

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1 hour post dose

Score:

> 1 - <= 2

Max. score:

2

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: conjunctival redness

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h dose dose

Score:

> 1 - < 4

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

No corneal, iris or conjunctival irritation was observed in the untreated eyes of the rabbits at any time point. Corneal irritation (mild opacity, scores of 1, involving app one quarter to less than three quaters of the corneas, scores of 1-3) was observed in the treated eyes of animals 1952 and 1953 at 1 h and 24hs post dose but resolved by 48hs post dose.
Moderate iritis (score of 1) was observed in animal 1952 at 1 h post dose with resolution by 24hs post dose.
Conjunctival redness (scores of 1) were observed beginning at 1h post dose, with a score of 2 for conjunctival redness for animal 1953 being observed at 24hs post dose. Scores of 1-2 for conjunctival redness persisted until day6.
Chemosis (scores of 1-4) were observed begining at 1h post dose with full resolution by 72hs. Scores of 2-3 for discharge were observed at 1h. Discharge resolved by 48h in 2 of 3 animals with irritation resolving in the remaining animal by 72h post dose. All 3 animals were observed to be normal on day 6 and the study was terminated.

Other effects:

No mortality was observed in the animals during to study. From one h post dose until completion of in-life, animals 1952 and 1953 appeared normal thoughout the study.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Eltesol SDIBP 35/B was found to be non-irritating to the eyes according to EEC criteria. Eltesol SDIBP 35/B was found to be mildly irritating (cat 2B) to the eyes according to GHS criteria.

Executive summary:

SDIBP needs to be classified with Xi, R36 and Eye Damage 2, H319 according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008, respectively.