Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., calcium salts

Endpoint summary

Description of key information

Calcium bis( di c8-c10, branched, c9 rich, alkylnaphthalene sulphonate) is irritating to skin and eyes. It is not corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study generally follows accepted procedures (Draize method) with an appropriate number of animals and dosing regime.

Qualifier:

according to guideline

Guideline:

other: FHSLA. CFR Title 21, para. 191.11.

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: abraded and shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Fivetenths of a milliliter (0.5 ml) of test material was placed under each patch. The patches were
secured with tape and covered with a plastic trunk band to pjevent evaporation.

Duration of treatment / exposure:

The rabbits were immobil ized in head stocks for 24 hours at which time the patches were
removed and the rabbits returned to their cages.

Observation period:

Skin lesions were evaluated at 24 and 72 hours

Number of animals:

6

Details on study design:

The rabbits were prepared by cl ipping the skin of the trunk free of hair. Epidermal abrasions were made over a 2-3 cm2
area on each rabbit. Two, 2.5 cm2 gauze patches were placed on each rabbit. One second patch over the abraded skin. Five-tenths
of a mill il iter of test material was placed under each patch. The patches were secured with tape and covered with a plastic
trunk band to pjevent evaporation. The rabbits were immobil ized in head stocks for 24 hours at which time the patches were
removed and the rabbits returned to their cages.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

average of 6

Time point:

other: 72

Score:

ca. 8.99

Reversibility:

no data

Remarks on result:

other: see attached tables for details

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72

Score:

ca. 0.66

Reversibility:

no data

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72

Score:

ca. 2.41

Reversibility:

no data

Irritant / corrosive response data:

See table.

Other effects:

No clinical symptoms reported.

Evaluation of Skin Reactions and Scoring Criteria

Erythema and Eschar Formation	Exposure Time hours	Average Exposure Unit Value
Intact Skin	24	1.83
	72	2.66
Abraded Skin	24	2.17
	72	2.33
Edema Formation	Subtotal	8.99
Intact Skin	24	0
	72	0.33
Abraded Skin	24	0
	72	0.33
	Subtotal	0.66
	Total	9.65
	Primary Irritation Score (Index)	2.41

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

NASUL 729 was determined to be a moderate skin irritant.

Executive summary:

NASUL 729 was evaluated for skin irritation following U.S. Federal Hazardous Substances Labeling Act (FHSLA) procedures. Rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 2-3 cm²area on each rabbit. Two, 2.5 cm²gauze patches were placed on each rabbit. One patch on the intact skin and a second patch over the abraded skin. Five-tenths of a milliliter (0.5) of test material was placed under each patch. The patches were secured with tape and covered with a plastic trunk band to prevent evaporation. The rabbits were immobilized in head stocks for 24 hours at which time the patches were removed and the rabbits returned to their cages. Skin lesions were evaluated at 24 and 72 hours and scored. NASUL 729 had primary irritation score of 2.41 indicating moderate skin irritation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study with no significant deviations.

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three male and three female (nulliparous and non-pregnant) New Zealand White rabbits were obtained from Hazleton Research Products, Inc.,
Denver, PA. and held in quarantine for 12 days. During quarantine the animals appearance and behavior were recorded daily.
The animals were individually housed in suspended cages with wire mesh bottoms. The absorbent paper under the cages was changed daily. The animals were fed a restricted diet (125 glday) of Purina High Fiber Lab Chow #5326 and received well water gd libitum. No contaminant was
expected to be present in the feed or water at a level sufficient to interfere with the study. The animals were transferred to another room on day 2 of the study. The room temperature of the first room was maintained at 66-69° F with a relative humidity of 34-82%. The room temperature of the
second room was maintained at 66-70° F with a relative humidity of 26-71%.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Single treatment with 10 days of observation

Observation period (in vivo):

Both eyes were grossly examined and the test eye scored by the Draize method at 1,24,48, and 72 hours and at 7 and 10 days after instillation of the test material.

Number of animals or in vitro replicates:

3 male and 3 female

Details on study design:

The eyes were prescreened for ocular defects and/or irritation on the day prior to testing. The left eye was designated as the test eye while the
right eye was designated as the control. A 0.1 ml aliquot was drawn into a 1 cc syringe and instilled into the left conjunctival sac by gently pulling
the lower lid away from the eyeball to form a cup. The eyelids were gently held together for approximately one second after instillation.
Both eyes were grossly examined and the test eye scored by the Draize method (See Appendix 1) at 1,24,48, and 72 hours and at 7 and 10 days after instillation of the test material. All eyes were also examined for the presence of corneal ulcerations at 24 hours using 2% sodium fluorescein.
Animals with ulcerations were reexamined with 2% fluorescein sodium during subsequent observations until the ulcerations were no longer
apparent. A plastic Elizabethan style collar was placed on each animal to prevent mechanical irritation of the eye. Mortality checks were performed daily. Clinical observations were performed daily except on the weekend. The animals were euthanized by overexposure to carbon dioxide on day 10 of the study.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

1.5

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0.1

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2.8

Reversibility:

fully reversible within: 10 days

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

3.3

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

Slight corneal opacities and iridial irritation were noted in 3/6 animals and moderate to severe conjunctival irritation in all animals at 1 hour. The number of animals with corneal opacities increased to 6/6 at 24 hours. The density of several opacities increased and corneal ulcerations
were present in all animals. The number of corneal opacities decreased to 3/6 at 48 hours and 1/6 at 72 hours. All opacities were clear by day 7. The number of corneal ulcerations decreased to 3/6 at 48 hours and 0/6 at 72 hours. Moderate to severe conjunctival irritation was still present
at 24 hours and diminished slowly over the remainder of the study.

Other effects:

Soft stool was noted in all animals on day 1 and in 2/6 animals on day 2. Decreased food consumption and decreased fecal output were noted in 2/6 animals on days 1 and 6, respectively. No other clinical observations were noted.

II.

Observation	1-Hr	24-Hrs	48-Hr	72-Hr	7-Days	10-Days	Mean Days1-3
Corneal Opacity	0.3	1.5	0.7	0.2	0.0	0.0	0.8
Iritis	0.5	0.0	0.0	0.0	0.0	0.0	0.0
Conjunctival Redness	2.7	2.8	2.0	1.2	0.7	0.0	2.0
Conjunctival Swelling	2.3	3.3	2.2	2.0	0.5	0.0	2.5

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

NA-SUL 729 is also an eye irritant according to EC guidelines because the combined mean conjunctival swelling score (24-, 48-, 72-hours) is
greater than 2.0.

Executive summary:

The acute ocular irritation of NA-SUL 729 was evaluated in three male and three female New Zealand White rabbits. A single 0.1 ml aliquot of the test material was instilled into the left conjunctival sac of each animal. The eye was gently held shut for approximately one second. A plastic Elizabethan collar was placed on each animal after dosing to prevent access to the test site. Both eyes were examined and the test eye scored according to the Draize method at 1, 24, 48, and 72 hours and at 7 and 10 days after instillation of the test material. All the test eyes were examined for the presence of corneal ulcerations at 24 hours with 2% sodium fluorescein. Those eyes with ulcerations were restained during each observation period until the ulceration healed. Clinical observations were recorded at approximately 1- and 4-hours after dosing and daily thereafter except on the weekend for the remainder of the study. Body weights were not recorded. All animals were sacrificed by over-exposure to carbon dioxide on day 10. Slight corneal opacities and iridial irritation was observed in 3/6 animals and moderate to severe conjunctival irritation in all animals at 1 hour. Corneal opacities were present in all animals at 24 hours along with corneal ulcerations. The number of corneal opacities decreased to 3/6 at 48 hours, 1/6 at 72 hours, and 0/6 by day 7. The number of corneal ulcerations decreased to 3/6 at 48 hours and 0/6 at 72 hours. Moderate to severe conjunctival irritation was still present at 24 hours and diminished slowly over the remainder of the study. The 24-hour mean Draize score was 33.0/110. The mean EC (24-,48-, and 72-hour) ocular irritation scores were 0.8 for corneal opacity, 0.0 for iritis; 2.0 for conjunctival redness; and 2.5 for conjunctival swelling. Soft stool was noted in all animals on day 1 and in 2/6 animals on day 2. Decreased food consumption and decreased fecal output were noted in 2/6 animals on days 2 and 6, respectively. No other clinical observations were noted.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on available in-vivo skin and eye-irritation studies the substance is to be classified into Category 2 for skin and eye irritation according to CLP (Regulation EC No 1272/2008) and Xi, R36/38 according to DSD (Directive 67/548/EEC).