Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-05-05 to 1987-05-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

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:

Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

EC Number:

932-051-8

Molecular formula:

not available - not a single isomer - see remarks

IUPAC Name:

Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Details on test material:

- Name of test material (as cited in study report): Marlon ARL (Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide)
- Physical state: solid (powder)
- Storage condition of test material: not mentioned
- Date of production: 1987-03-24
pH (20 g/L): 8 - 10

Test animals / tissue source

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours, and 6, 8, 10, 13, 17 and 21 days after application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hours

Score:

39.92

Max. score:

110

Reversibility:

not fully reversible within: 21 d

Irritant / corrosive response data:

AVERAGE SCORE (24, 48 and 72 h)
- Cornea: 1.44
- Iris: 0.56
- Conjunctivae (Redness): 3.0
- Conjunctivae (Chemosis): 1

Any other information on results incl. tables

Score at time point/Reversibility	Cornea	Iris	Conjunctivae (redness)	Conjunctivea (Chemosis)
24 h	1/1/1	0/1/1	3/3/3	1/1/1
48 h	2/2/1	1/1/0	3/3/3	1/1/1
72 h	2/2/1	0/1/0	3/3/3	1/1/1
Reversiblity	n	n	n	n
mean	1.44	0.56	3	1

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The test item had irritating effects on the eyes. All animals showed irreversible damages of the iris, 1 of 3 also of the conjunctivae and the cornea, the last of the cornea but not of the conjunctivae (not reversible during the observation period of 21 d). Because of the irreversible effects it has to be classified in categorie 1.