Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 11 March 1994 to 29 June 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is sufficiently documented. No certificate of analysis is available.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

sodium isopropylnaphtalene sulfonate

IUPAC Name:

sodium isopropylnaphtalene sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

See confidential details on test material section

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Source: Animals were received from Ace Animals on 1/18, 2/15 and 2/22/94.
- Age at study initiation: The animals were born the week of 10/24 through 12/12/93.
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: The animals were housed 1/cage in suspended cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow (Diet # 5321)
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: three days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): No data on temperature but the animal room was temperature controlled.
- Humidity (%): data not available
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: data not available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL:
- Amount applied (volume or weight with unit): 0.1 ml equivalent of test material introduced into the conjunctival sac of the each eye
- Concentration (if solution): not applicable
- pH: no applicable

VEHICLE: /

Duration of treatment / exposure:

Single conjunctival instillation

Observation period (in vivo):

1 hour, and days 1, 2, 3 and 7 after the instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : 20-30 seconds after instillation of the test article, the left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed.


SCORING SYSTEM: The eyes were examined and scored by the Draize technique at 1 hour post dose and again on days 1, 2, 3 and 7 post dose.

TOOL USED TO ASSESS SCORE: data not available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1.33 - <= 2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 1.33 and 1.33 for corneal opacity.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks:

at day 7

Remarks on result:

other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.0 for iris lesions.

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2 - <= 2.7

Max. score:

3

Reversibility:

not reversible

Remarks:

at day 7 for 1 animals

Remarks on result:

other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 2.7, 2.0 and 2.0 for redness of the conjunctiva

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2.33 - <= 3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Unwashed: Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 2.33 and 3.0 for chemosis.

Irritant / corrosive response data:

Unwashed: Corneal opacity, noted in 3/3 eyes, persisted up to day 7. Iritis, noted in 3/3 eyes, cleared by day 7. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye and improved to slight in two eyes.
Washed: Corneal opacity was noted in two eyes on day 7. Iritis, noted in 3/3 eyes, persisted up to day 7 in one eye. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye, cleared in one eye and improved to slight in the third eye.

Other effects:

There were no signs of systemic toxicity noted during the observation period.

Any other information on results incl. tables

Result Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Unwashed right eye:

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	2/0h/0h	1/1/1	2/2/2	3/3/3
24 h	2/0h/0h	1/1/1	2/2/2	3/3/3
48 h	2/2/2	1/1/1	3/2/2	3/2/3
72 h	2/2/2	1/1/1	3/2/2	3/2/3
Average 24h, 48h, 72h	2/1.33/1.33	1/1/1	2.7/2/2	3/2.33/3
Reversibility*)	n.	c.	n.c.	n.
Average time (unit) for reversion	-	Day 7	Day 7 (2/3 eyes)	-

 

*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

         

h: lack of normal luster

 

Washed left eye:

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/2	2/3/3
24 h	0h/0h/0h	0/1/0	2/2/2	2/3/3
48 h	0h/0h/0h	1/1/0	3/2/2	2/3/3
72 h	0h/0h/0h	1/1/0	3/2/2	2/3/3
Average 24h, 48h, 72h	0/0/0	0.66/1/0	2.66/2/2	2/3/3
Reversibility*)	n.c. (score :2 in 2 animals at day 7)	n.c. (score :1 in 1 animal at day 7)	n.c. (score : 1 and 2 in 2 animals at day 7)	n.c. (score :2 in 1 animal at day 7)
Average time (unit) for reversion	-	-	-	-

 

*) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

         

h: lack of normal luster

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE, and Eye Damage Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eye damages at the end of the observation period (7 days).

Executive summary:

In a primary eye irritation study (1994), 0.1 ml equivalent of the test article was instilled into the conjunctival sac of each eye of New Zealand Albino rabbits (3 animals). 20-30 seconds after instillation of the test article, the left eye of each rabbit was flushed for one minute with lukewarm water. The right eye of each animal remained unwashed. Animals were then observed for 7 days. Irritation was scored by the method of Draize.

For unwashed eyes : Corneal opacity, noted in 3/3 eyes, persisted up to day 7. Iritis, noted in 3/3 eyes, cleared by day 7. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye and improved to slight in two eyes.

Mean scores calculated for each animal over 24, 48 and 72 hours were 2.0, 1.33 and 1.33 for corneal opacity; 1.0, 1.0 and 1.0 for iris lesions; 2.7, 2.0 and 2.0 for redness of the conjunctiva and 3.0, 2.33 and 3.0 for chemosis.

For washed eyes: Corneal opacity was noted in two eyes on day 7. Iritis, noted in 3/3 eyes, persisted up to day 7 in one eye. Moderate conjunctival irritation, noted in 3/3 eyes, persisted up to day 7 in one eye, cleared in one eye and improved to slight in the third eye.

Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE and Eye Damage, Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eyes damages at the end of the observation period (7 days).