Sulfuric acid, mono-C14-16 (even numbered)-alkyl esters, sodium salts

Endpoint summary

Description of key information

No data are available for the target substance Sulfuric acid, mono-C14-16 (even numbered)-alkyl esters, sodium salts (CAS 91648-54-3). Therefore, read-across from structural analogue substances has been applied.

skin irritation (OECD 404): irritating

Read-across from source substances Sulfuric acid, mono-C12-18-alkyl esters, sodium salts (CAS 68955-19-1) and Sulfuric acid, mono-C12-16-alkyl esters, sodium salts (CAS 73296-89-6)

eye irritation (OECD 405): highly irritating/corrosive

Read-across from source substance Sulfuric acid, mono-C12-16-alkyl esters, sodium salts (CAS 73296-89-6)

SCLs according to Regulation (EC) No. 1272/2008 (CLP):
>=10% - <20% Eye Irrit. Cat.2, R36
<10% No Classification

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

According to Guideline.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Interpretation of results:

other: Skin irrit. 2, H315. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack on details of test substance.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

According to Guideline.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: Skin irrit. 2, H315. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack on details of test substance. However details were achieved from the sponsor.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

According to Guideline.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

2

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.8

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.6

Max. score:

4

Reversibility:

fully reversible within: 21 days

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Only 7 d recovery instead of 21 d, Some data not reported (e.g. environmental conditions)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

n.a.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Grade 1 in one animal

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Grade 1 in two animals

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: Eye irrit. 2, H319. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Only14 d recovery instead of 21 d, Some data not reported (e.g. environmental conditions)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

n.a.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Reference 4

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1977-12-15 to 1978-03-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Guideline study performed before GLP was set into force.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Marland Breeding Farms, Inc
- Age at study initiation: Not available
- Weight at study initiation: Not available
- Housing: animals were individually housed
- Diet (e.g. ad libitum): Not available
- Water (e.g. ad libitum): Not available
- Acclimation period: Not available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not available
- Humidity (%): Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Not available


IN-LIFE DATES: From: 1977-12-15 To: 1978-03-10

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (eye non rinsed /rinsed)
- Concentration (if solution): 50% w/w solution of test material in distilled water (22% a.i.)


VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of treatment / exposure:

Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w solution of the test material (B0010) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as group I, followed at 4 seconds by a 20 ml lukewarm tap water rinse (Group II).

Observation period (in vivo):

1 hour , and on days 1, 2, 3, 4, 7 ,14, 21 and 28 following compound administration.

Number of animals or in vitro replicates:

Group I - 3 animals (50% w/w solution of test material B0010 in distilled water, non-rinsed)
Group II - 3 animals (50% w/w solution of test material B0010 in distilled water, rinsed)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group I - Unwashed, Group II washing with 20 ml lukewarm tap water
- Time after start of exposure: 4 seconds in group II


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Day 1-3

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Day 1-3

Score:

0.8

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: Day 1-3

Score:

2.1

Max. score:

3

Reversibility:

not fully reversible within: 21 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Day 1-3

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Irritant / corrosive response data:

Group I (Unwashed eye)
Overall irritation score at 1 hour: 6
Overall irritation score at 1 day: 7.67
Overall irritation score at 2 days: 6.67
Overall irritation score at 3 days: 5.33
Overall irritation score at 4days: 5.33
Overall irritation score at 7 days: 3.33
Overall irritation score at 14 days: 0.33
Overall irritation score at 21 days: 0.66
Group II (Washed eyes)
Overall irritation score at 1 hour: 4.00
Overall irritation score at 1 day: 6.34
Overall irritation score at 2 days: 5.33
Overall irritation score at 3 days: 4.33
Overall irritation score at 4 days: 4.33
Overall irritation score at 7 days: 1.66
Overall irritation score at 14 days: 1.33
Overall irritation score at 21 days: 0
Overall irritation score at 28 days: 0

Other effects:

None

Irritation parameter	Basis	Time point		Max. score	Reversibility	Remarks
overall irritation score	mean	14 and 21 days		0.66	not fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
Cornea score and iris score	mean	14 and 21 days	0	0	othere: No corneal and iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
conjunctivae and chemosis score	mean one animal with grade 1, two animals with grade 0	14 and 21 days	> = 0 -< = 1	1	not fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, non rinsed
overall irritation score	mean	1 hour		4.00	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean three animals with grade 1	1 hour	1	1	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
Iris score	mean	1hour	0	0	other: no iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean one animal with grade 1, two animals with grade 2	1 hour	> =1 -< =2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal with grade 2, two animals with grade 1	1 hour	> =1 -<=2	2	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	1 days		6.34	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 1, two animals with grtade 2	1 days	> = 1 - <=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
iris score	mean two animals with garde 1, one animal with grade 0	1, 2, 3 and 4 days	> =0 - <=1	1	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean two animals with grade 2, one animal with grade 3	1 and 2 days	> =2 - <=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal grade 0, one animal with grade 2, one animal with grade 3	1 days	>=0 - <=3	3	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	2 days		5.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean two animals with grade 2, one animal with grade 0	2, 3 and 4 days	>=0 -<=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean one animal with grade 0, one animal with grade1, one animal with grade 2	2 and 3 days	>= 0- <=3	3	fully reversible within: 7 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	3 and 4 days		4.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean two animals with grade 2, one animal with grade 0	3 and 4 days	>= 0 -<=2	2	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	7 days		1.66	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 0, one animal with grade 1, one animal with grade 3	7 days	>= 0 -<=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
iris score	mean	7 and 14 days	0	0	other : no iridal irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
conjunctivae score	mean one animal with grade 1, two animals with grade 0	7 and 14 days	>=0 -<=1	1	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
chemosis score	mean	7 and 14 days	0	0	other : no conjunctival chemosis was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation score	mean	14 days		1.33	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
cornea score	mean one animal with grade 0, one animal with grade 1, one animal with grade 3	14 days	>=0 - <=3	3	fully reversible within: 21 days	0.1 ml of 50% w/w solution of test material in distilled water, rinsed
overall irritation, cornea, conjunctivae and chemosis score	mean	21 and 28 days	0	0	other : no ocular irritation was observed	0.1 ml of 50% w/w solution of test material in distilled water, rinsed

GHS Rating and Calculations

Animals no.	GHS Classification	What It means?	Cornea	Iris	Conjunctival redness	Conjunctival chemosis	Days to clear
354	2a	Irritating to eyes	2	0.67	2	1.67	21 days
355	2a	Irritating to eyes	2	0.67	2	1.33	21 days
356	2a	Irritating to eyes	2	1	2.33	2	21 days

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Executive summary:

Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w solution of the test material B0010 (44% KAS paste) in distilled water was instilled into one eye each of three rabbits (Group I); a second group of three rabbits received the same treatment as group I, followed at 4 seconds by a 20 ml lukewarm tap water rinse (Group II). The eyes were examined for corneal opacity, iritis and conjunctivitis at one hour and on days 1, 2, 3, 4, 7, 14, 21 and 28 following treatment and were graded using Draize ocular irritation grading system.

All three eyes in Group I were assigned positive scores for corneal opacity and ulceration, iritis, conjunctival redness and chemosis. Two eyes were clear on day 28 of the study and showed signs of eye irritation on day 21 of the study.

Three eyes in Group II were assigned positive scores for corneal opacity. Three eyes were observed to have positive scores for conjunctival redness and two for chemosis. In addition, two eyes were assigned positive score for iritis. One eye was clear on day 3 and two on day 21 of the study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no data on skin and eye irritation / corrosion available for C14-16 AS Na (CAS 91648-54-3). Therefore these endpoints are covered by read across to structurally related alkyl sulfates (AS). The possibility of a read-across to other alkyl sulfates in accordance with Regulation (EC) No 1907/2006 Annex XI 1.5 “Grouping of substances and read-across approach” was assessed. In Annex XI 1.5 it is given that a read-across approach is possible for substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS read-across approach show structural similarity. The most important common structural feature of the source and target substances is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralized with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the source and target substances in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS have similar physicochemical, environmental and toxicological properties. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

Skin irritation

There is one relevant study for the read-across substance C12-18 AS Na (CAS 68955-19-1) and one study for the read-across substance C12-16AS Na (CAS 73296-89-6) available addressing skin irritation. Both studies are accounted for in a Weight-of-Evidence (WoE) approach.

The study conducted with C12-18 AS Na (CAS 68955-19-1, analytical purity 89%) was performed according to OECD Guideline 404 under semi-occlusive conditions (BASF, 1994). Each of three New Zealand White rabbits was exposed for 4 h to 0.5 g of the unchanged test item and was observed for a period of 14 days for erythema and edema. The mean erythema score (24, 48 and 72 h reading) and the mean edema score were 3 and 2.3, respectively. Both effects were fully reversed within the 14 days observation period.

The study conducted with C12-16 AS Na (CAS 73296-89-6, analytical purity 30%) was performed according to OECD Guideline 404 under semi-occlusive conditions (Kao, 1997a). Each of three New Zealand White rabbits was exposed for 4 h to 0.5 mL of the unchanged test item and was observed for a period of 14 days for erythema and edema. The mean erythema score (24, 48 and 72 h reading) and the mean edema score were 3 and 3, respectively. Edema fully reversed within the 14 days observation period while erythema persisted until day 14 in one animal (grade 1).

Conclusion on the skin irritating properties of C14-16 AS Na (CAS 91648-54-3)

Based on the above mentioned results with different concentrations of structurally related alkyl sulfates it can be expected that C14-16 AS Na (CAS 91648-54-3) possess irritating properties to the skin.

According to Reglation (EC) No. 1272/2008 (CLP) ≥ 10% C14-16 AS Na (CAS 91648-54-3) needs to be classified as H315, Skin Irrit. 2. No classification is required below 10% C14-16 AS Na (CAS 91648-54-3).

Eye irritation

No data are available for the neat substance allowing a definitive classification of C14-16 AS Na (CAS 91648-54-3). Therefore, a read-across from C12-16 AS Na (CAS 73296-89-6).

An OECD guideline 405 study was performed with 0.1 mL pure C12-16 AS Na (CAS 73296-89-6, analytical purity 30%) on three New Zealand White rabbits (Kao, 1997b). The observation period was 21 days. Eye reactions were scored 1, 24, 48 and 72 h after treatment. Further observations were performed on days 7, 14, and 21 after application. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 1, 0.2, 2.8 and 3.6. The iritic effects reversed within 72 h and chemosis within the 21 day observation period. The effects observed on cornea and the redness of the conjunctiva were not fully reversible within 21 days. Thus the substance produced irreversible effects on the eye at a concentration of 30% within this study.

Setting of SCLs for eye irritation

As corrosion and irritation depends on the concentration of the substance in a solvent, further studies with lower concentrations of the read across substances were also considered to assess whether specific concentration limits can be set. For this purpose, one study with C12-13 AS K (CAS 91783-22-1) and two studies with C10-16 AS Na (CAS 68585-47-7) with a concentration range of 10 to 22% were evaluated.

In the study with C12-13 AS K (CAS 91783-22-1, analytical purity 44%) 0.1 mL of the diluted test item (1:1 mixture with water) was applied to one eye of each of three New Zealand White rabbits according to OECD guideline 405 (P&G, 1978b) without rinsing. In a second experiment with additional 3 rabbits the procedure was repeated but the treated eye was rinsed with 20 mL of lukewarm tap water 4 seconds after application of the test item. The eye reactions were recorded 1, 24, 48, 72 h and 4, 7, 14, 21 and 28 days in both experiments. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores of experiment 1 were 2, 0.8, 2.1 and 1.7. The findings reversed in 2/3 animals within 14 days while 1/3 animals showed signs of irritation after 21 days. However, the signs of irritation show a clear tendency to decrease with time. No reading on day 28 was possible. Findings in the experiment with rinsing of the eye were less pronounced but irritating properties were also observed. As the ocular findings clearly reversed within 21 days the result of the study indicate the concentration of 22% to be the turning point between classification as severe damage to the eye and eye irritation.

The first study with 0.1 mL undiluted C10-16 AS Na (CAS 68585-47-7, analytical purity 10%) was performed similar to OECD guideline 405 (Stepan, 1980a) on three New Zealand White rabbits with an observation period of 7 days. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores over all animals were 1.4, 0.7, 2 and 1.6. Corneal opacity was still observed in 1/3 animals (score 1) and conjunctival redness was still present in 2/3 animals (both score 1) upon reading at day 7. Depending on the classification requirements the test substance is not or only moderate irritating to the eye at a concentration of 10%.

The second study with C10-16 AS Na (CAS 68585-47-7, analytical purity 10%) was performed similar to OECD guideline 405 (Stepan, 1980b). 0.1 mL of the undiluted test item was instilled into one eye of each of three New Zealand White rabbits. Eye reactions were scored at least 24, 48 and 72 h and 14 days after application of the test item. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 0.9, 0.7, 1.9 and 1.6. All findings were fully reversible within the observation period. Thus, the test substance showed no eye irritating properties at a concentration of 10%.

Conclusion on the eye irritating properties of C14-16 AS Na (CAS 91648-54-3)

Based on the above mentioned results with different concentrations of structurally related alkyl sulfates a cut of value for classification as severe irritating to eyes is set at a concentration of 20% and for classification as irritating at a concentration of 10%. Since the available data of the read-across substance C10-16 AS Na (CAS 68585-47-7) indicates no or only mild eye irritation potential at a concentration of 10%, no classification is required below 10% C14-16 AS Na (CAS 91648-54-3).

According to CLP ≥ 20% C14-16 AS Na (CAS 91648-54-3) needs to be classified as H318, Eye Dam. 1. Based on a weight of evidence approach ≥ 10 % - < 20% C14-16 AS Na (CAS 91648-54-3) needs to be classified as H319, Eye Irrit. 2 according to CLP. Below 10% no classification at all is required.

 

No data on respiratory irritation are available. AS is mainly used in liquid media and due to its very low vapour pressure [2] inhalation is not viewed as a significant route of exposure. Inhalation of AS may occur by inhalation of aerosols generated by spray cleaners or by inhalation of detergent dusts (e.g. washing powder). In both cases the substance will be used in low concentrations. However in case the substance is available as neat powder the substance will also be classified as STOT Single exp. Cat 3 according to CLP at concentrations exceeding 20%

 

[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 (CLP) the test substance needs to be classified with Skin Irritation Category 2, H315 and Eye Dam.1, H318, respectively. It could be shown with experimental data on eye irritation that at 10 to 20% active substance only the classification Eye Irritating Category 2 according to Regulation (EC) No. 1272/2008 (CLP) remains. Below 10% active substance no classification at all is necessary. Hence, the Generic Concentration Limits (GCLs) can be substituted by the mentioned specific ones (SCLs).