Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts

Endpoint summary

Description of key information

According to a guideline dermal irritation study of the analogue substance linear CaDDBS, the primary dermal irritation score of linear CaDDBS was 7.0, indicating that BABS Na salt is a primary dermal irritant.

In an eye irritation study also performed on the analogue substance linear CaDDBS, rabbits were exposed to 0.1 ml of 100% test substance in the eye for 24 hrs. Results show that the test substance may cause serious damage to the eyes, and therefore BABS Na salt is also likely to cause serious damage to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP laboratory study

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC Design, 16 CR 1500

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks old
- Weight at study initiation: Not stated
- Housing: Individually housed in stainless steel cages in a temperature, humidity and light controlled room in accordance with the recommendations contained in the National Academy Press 1996 "Guide for the Care and Use of Laboratory Animals."
- Diet (e.g. ad libitum): ad libitum Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

Observed at 4.5, 24, 72, 168 and 336 hours after application

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 1 inch square for each site
- Type of wrap if used: two layer gauze patch secured with non-irritating porous adhesive tape and then the entire site was covered with a 4 mil plastic and secured with more adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess removed after 4 hours
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring system

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Average of 24 and 72 hour scores

Score:

7

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritant / corrosive response data:

See table

Primary Dermal Irritation

Rabbit Number	4.5 hours
	Unabraded		Abraded
	ER	ED	ER	ED
274	3	4	3	4
275	3	4	4	4
276	3	4	3	4
Average	3.0	4.0	3.3	4.0
Rabbit Number	24 hours
	Unabraded		Abraded
	ER	ED	ER	ED
274	3	4	3	4
275	3	4	3	4
276	3	4	3	4
Average	3.0	4.0	3.0	4.0
Rabbit Number	72 hours
	Unabraded		Abraded
	ER	ED	ER	ED
274	4	2	4	2
275	4	4	4	4
276	4	3	4	3
Average	4.0	3.0	4.0	3.0
Rabbit Number	7 days
	Unabraded		Abraded
	ER	ED	ER	ED
274	4	1	4	1
275	4	1	4	1
276	4	1	4	1
Average	4.0	1.0	4.0	1.0
Rabbit Number	14 days
	Unabraded		Abraded
	ER	ED	ER	ED
274	2	1	2	1
275	2	1	3	1
276	2	1	2	1
Average	2.0	1.0	2.3	1.0

ER = Erythema; ED = Edema

24 hour score: 14.0

72 hour score: 14.0

Total score: 28.0

Primary dermal irritation score: 7.0

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

The test substance is a primary dermal irritant.

Executive summary:

The test substance, Ninate 60E (Branched CaDDBS), was tested for primary dermal irritation in accordance with FHSA/CPSC Guidelines. The sample was applied at a dose of 0.5 mL per site to unabraded and abraded skin sites in a clipped area of each of three albino rabbits. The test sites were occluded and the test material remained on the skin for a 4 hour contact period. Application sites were graded using the Draize scoring system at 4.5, 24, 72, 168 and 336 hours after application. The primary dermal irritation score was 7.0, indicating that the substance is a primary dermal irritant. Based on these results, BABS Na salt is classified as CLP category 2 (irritant) and under DSD is classified as R38, irritating to skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study done according to OECD Guideline 405, but limited information given in the study report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

other: New Zealand

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hrs

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

> 1 - < 3

Remarks on result:

other: May cause serious damage to eyes

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Data not available

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is classified as R41, may cause serious damage to eyes, under the DSD.

Executive summary:

Rabbits were exposed to 0.1 ml of 100% test substance (Branched CaDDBS) in the eye for 24 hrs. Results show that the test substance may cause serious damage to the eyes. Based on these results, BABS Na salt is classified as a severe irritant (CLP category 1) with a risk of severe damage to the eyes (DSD (R41)).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In cases where data on BABS Na salt is not available, data on analogue substances are used. The analogue substances used included: 1) the sodium salt of linear alkylbenzene sulfonate (commonly known as LAS or Na-LAS), 2) the calcium salt of branched alkylbenzene sulfonate (commonly known as Branched CaDDBS) and 3) the calcium salt of linear alkylbenzene sulfonate (commonly known as Linear CaDDBS). LAS is the sodium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10 to C13 and averaging 11.6. The primary structure is a C10 to C13 linear alkyl chain with a para-substituted benzene sulfonic acid sodium salt group attached at any of the secondary alkyl carbon positions. Branched CaDDBS is the calcium salt of branched alkylbenzene sulfonic acid with alkyl chain lengths ranging from C11 to C13. Linear CaDDBS is the calcium salt of linear alkylbenzene sulfonic acid with alkyl carbon chain lengths ranging from C10 to C14. BABS Na salt is the sodium salt of branched alkylbenzene sulfonic acid with alkyl chain lengths ranging from C11 to C13. The primary difference between LAS and BABS Na salt is the alkyl chain, branched vs. linear. The primary difference between Branched CaDDBS and BABS Na salt is the salt, calcium vs. sodium. Given their structural and functional similarities, LAS, Branched CaDDBS, and Linear CaDDBS are good analogues for read-across for instances where data are available on them but not on BABS Na salt. When studies on the analogues are available, all data are provided and the most conservative (most health protective) data is used for classification and labeling.

The substance linear CaDDBS was tested for primary dermal irritation in accordance with FHSA/CPSC Guidelines. The sample was applied at a dose of 0.5 mL per site to unabraded and abraded skin sites in a clipped area of each of three albino rabbits. The test sites were occluded and the test material remained on the skin for a 4 hour contact period. Application sites were graded using the Draize scoring system at 4.5, 24, 72, 168 and 336 hours after application. The primary dermal irritation score was 7.0, indicating that the substance is a primary dermal irritant. This was the most conservative value of the four dermal irritation studies presented. The remaining three read-across studies also had a result of irritating to skin.

In a linear CaDDBS study, rabbits were exposed to 0.1 ml of 100% test substance in the eye for 24 hrs, according to OECD guideline 405. Results show that the test substance may cause serious damage to the eyes. The additional four read-across studies had results ranging from irritating to irreversible damage to the eyes.

Justification for selection of skin irritation / corrosion endpoint:

The selected study represents the conservative results, with a primary irritation index of 7.

Justification for selection of eye irritation endpoint:

The selected study was one of two studies performed on analogue substances that had the most conservative result, irreversible damage to the eyes with a irritation score of up to 3.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

With regards to skin irritation, BABS Na salt is classified as CLP category 2, irritant, and under DSD is classified as R38, irritating to skin. For eye irritation, BABS Na salt is classified as a severe irritant (CLP category 1), with risk of severe damage to the eyes (R41).