Phenol, dodecyl-, branched, sulfurized

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:

16th to 25th December 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study following GLP. The reliability is reduced as the study is being used for read-across purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

122384-87-6

Cas Number:

122384-87-6

IUPAC Name:

122384-87-6

Details on test material:

122384-87-6/ 68784-26-9/122384-86-5/68784-25-8. Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased.
Test material dosed as received, purity not provided.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2746 to 2999 grams at initiation of dosing
- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in accordance with standard operating procedures.
- Diet (e.g. ad libitum): PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322 was offered at approximately 150 g per day during the study. Analysis of feed was performed and provided by the manufacturer.
- Water (e.g. ad libitum): Municipal water was provided ad libitum. Water was analyzed in accordance with standard operating procedures. Contaminants were not present in animal feed or water at levels expected to interfere with the objective of this study.
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 68.2-68.8°F
- Humidity (%): 30.2-44.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml/right eye

Duration of treatment / exposure:

The test article was placed directly into the cupped lower conjunctival sac of each rabbit's right (test) eye. The eyelids were held closed for approximately one second after instillation. Left eyes were manipulated in an identical manner to simulate the dosing of the right eyes.

Observation period (in vivo):

Treated eyes were examined at 24, 48 and 72 hours and on Days 4 and 7 following treatment according to the Draize methodology. The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.

Number of animals or in vitro replicates:

six, 2 males/4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unwashed exposure.

SCORING SYSTEM:
Both eyes of all rabbits were examined macroscopically for ocular irritation in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted.

TOOL USED TO ASSESS SCORE:
An ophthalmoscope was used during these observations to examine the corneal tissue. In addition, both eyes were further examined at 72 hours and on day 7 with sodium fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour after instillation of test material

Score:

5.3

Remarks on result:

not measured/tested

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

0

Reversibility:

other: no effetcs seen

Remarks on result:

not measured/tested

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

1.5

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 hours

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
M.A.S. - Maximum Average Score for 1 hour was 5.3.

Any other information on results incl. tables

There were no deaths during the study.

The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.

There were no remarkable body weight changes noted during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.

Executive summary:

In an eye irritation study conducted to OED method 405 in compliance with GLP, the primary ocular irritation potential of the test material was evaluated with New Zealand White rabbits.

There was one group of six albino rabbits that received a single, unwashed exposure. Each 0.1-m1 dose of the test article was instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control.

The eyes were examined for ocular reactions in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 72 hours and on day 7.

Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.

The Maximum Average Score for the test material was 5.3 at one-hour post-instillation.

The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating in accordance with the CLP Regulation EC 1272/2008, and also Directive 67/548/EEC (Dangerous Substances Directive).

The study is being used as read across from a structurally similar substance.