Sulfuric acid, mono-C16-20-alkyl esters, sodium salts

Endpoint summary

Description of key information

No data are available for the target substance Sulfuric acid, mono-C16-20 (even numbered)-alkyl esters, sodium salts (CAS 91648-55-4). Therefore, read-across from structural analogue substances has been applied.

Oral LD50 (OECD 401), rat = 4010 mg/kg bw

Read-across from structural analogue source substances Sulfuric acid, mono-C12-18-alkyl esters, sodium salts (CAS 68955-19-1)

Dermal LD50 (OECD 402), rabbit > 2000 mg/kg bw (limit test)

Read-across from structural analogue source substance sodium octyl sulfate (CAS 142-31-4)

Acute toxicity by inhalation was not tested according to REGULATION (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment Adopted according to OECD SIDS or other official EU regulation procedures (public available peer reviewed source).

Principles of method if other than guideline:

Method: other: P&G standard procedure #1; comparable or similar to OECD Guideline 401.

GLP compliance:

not specified

Species:

rat

Strain:

other: Cox CD

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2500, 3500, 4900 and 6850 mg/kg bw

No. of animals per sex per dose:

5

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 010 mg/kg bw

Based on:

act. ingr.

LD50 (confidence limits): 3390 - 4740 mg/kg

MORTALITY
-Time of death: all deaths occurred within 24 hrs to 7 days after dosing

-Number of deaths at each dose:
2500 mg/kg:  0/10
3500 mg/kg:  5/10
4900 mg/kg:  6/10
6850 mg/kg: 10/10


CLINICAL SIGNS
>= 2500 mg/kg: slight to moderate decreased motor activity and  respiratory

 rate, blanching, abdominal griping and diarrhoea
>= 3500 mg/kg: slight degrees of haemorrhagic rhinitis; persistent 

symptoms and delayed deaths were noted up to seven days post-treatment
   6850 mg/kg: slight loss of corneal reflex and pupilary responses

NECROPSY FINDINGS
necropsy of survivors: no abnormalities

POTENTIAL TARGET ORGANS
-none

SEX-SPECIFIC DIFFERENCES
-none

Interpretation of results:

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

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Principles of method if other than guideline:

Method: other: according to Directive 79/831/EEC, Annex V, part B

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 100 mg/kg bw

Based on:

act. ingr.

MORTALITY
-none

CLINICAL SIGNS
-decreased motility in males and salivation after dosing

NECROPSY FINDINGS
-hydrometra in one female (not substance related)

Interpretation of results:

study cannot be used for classification

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

not specified

Route of administration:

oral: drinking water

Vehicle:

not specified

Doses:

no data

No. of animals per sex per dose:

5

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 1 886 mg/kg bw

Based on:

act. ingr.

Only LD50 value given

Interpretation of results:

study cannot be used for classification

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

4 010 mg/kg bw

Quality of whole database:

The whole data base is conclusive and of high quality.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

Acute toxicity by inhalation was not tested according to REGULATION (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Standard Procedure #10, Rabbit Acute Percutaneous Toxicity Studies

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

3 animals instead of 5 animals were used. The observation period was 72 h instead of 14 d. The test substance was applied under occlusive instead of semi-occlusive conditions.

Principles of method if other than guideline:

Three male and three female New Zealand Albino rabbits each in the weight range of 2200-2800 g constitute a test group. Animals are randomized into groups according to sex and weight. Areas on the animals' backs approximating 10% of the total body surface are clipped prior to treatment with an Oster small animal clipper. The backs of three animals (2 females, 1 male) are abraded and three (2 males, 1 female) are left intact. Abrading is accomplished with a clipper head which produces minor incisions through the stratum corneum which are not deep enough to produce bleeding.
2 g/kg of the undiluted test material are applied to the test sites and spread with a tongue depressor over the clipped area. A material in dry form may be moistened, if necessary. The test material is covered with a layer of gauze and covered with a rubber dam and secured in place by several wrappings of 3 inch Elastoplast tape. The animals are placed in harnesses to prevent removal of the bandage and test material.
The harnesses and wrappings are removed after 24 hours. At this time the skin is evaluated for degree of irritation. Daily observations are made and recorded for 14 days thereafter. On the fourteenth day the animals are counted, weighed and sacrificed. If deaths were to occur due to this test procedure, an LD50 value could be determined. In our experience, however, with the types of materials that we test, this does not occur so that the test provides information relative to primary irritation.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10%
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg

Duration of exposure:

24 h

Doses:

2 g/kg bw (corresponding to 500 mg a.s./kg bw)

No. of animals per sex per dose:

3

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

act. ingr.

Mortality:

None

Clinical signs:

Severe erythema and eschar formation at 24 h; necrosis by Day 5–21; necrotic tissues sloughed and leaving skin hyper-pigmented at Day 21; no further signs of systemic toxicity than body weight changes.

Body weight:

Weight loss in all except one rabbit.

Gross pathology:

No data

Interpretation of results:

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

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Standard Procedure #10, Rabbit Acute Percutaneous Toxicity Studies

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

3 animals instead of 5 animals were used.The observation period was 72 h instead of 14 d. The test substance was applied under occlusive instead of semi-occlusive conditions.

Principles of method if other than guideline:

Three male and three female New Zealand Albino rabbits each in the weight range of 2200-2800 g constitute a test group. Animals are randomized into groups according to sex and weight. Areas on the animals' backs approximating 10% of the total body surface are clipped prior to treatment with an Oster small animal clipper. The backs of three animals (2 females, 1 male) are abraded and three (2 males, 1 female) are left intact. Abrading is accomplished with a clipper head which produces minor incisions through the stratum corneum which are not deep enough to produce bleeding.
2 g/kg of the undiluted test material are applied to the test sites and spread with a tongue depressor over the clipped area. A material in dry form may be moistened, if necessary. The test material is covered with a layer of gauze and covered with a rubber dam and secured in place by several wrappings of 3 inch Elastoplast tape. The animals are placed in harnesses to prevent removal of the bandage and test material.
The harnesses and wrappings are removed after 24 hours. At this time the skin is evaluated for degree of irritation. Daily observations are made and recorded for 14 days thereafter. On the fourteenth day the animals are counted, weighed and sacrificed. If deaths were to occur due to this test procedure, an LD50 value could be determined. In our experience, however, with the types of materials that we test, this does not occur so that the test provides information relative to primary irritation.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 10%
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg

Duration of exposure:

24 h

Doses:

2 g/kg bw (corresponding to 500 mg a.s./kg bw)

No. of animals per sex per dose:

3

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

act. ingr.

Mortality:

None

Clinical signs:

Severe erythema and slight eschar formation at 24 h; necrosis by Day 2–14 with sloughing of the skin by Day 8–14; hyper-pigmentation of new skin by Day 14; no signs of systemic toxicity.

Body weight:

Decrease in body weight (220 g) during 14 d observation period in one rabbit with intact skin.

Gross pathology:

No data

Interpretation of results:

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

Reference 3

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.4 - 2.9 kg
No further data are available.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25% (abraded and shaved)
- Type of wrap if used: occlusive (Elastoplast)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg

Duration of exposure:

24 h

Doses:

2 g/kg bw (corresponding to 500 mg a.s./kg bw)

No. of animals per sex per dose:

3

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

act. ingr.

Mortality:

None

Clinical signs:

Moderate to severe erythema, edema, and atonia were observed in all animals during this study. By Day 6 of the study, all animals showed signs of desquamation and fissuring. Five animals were observed to have moderate to marked desquamation and one animal had slight desquamation. Moderate to marked fissuring was noted in all animals in this study. In addition, all animals had eschar formation and exfoliation. Signs of dermal irritation were evident in all six anmals at the termination of this study.

Body weight:

No weight losses.

Gross pathology:

No data

Interpretation of results:

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

Reference 4

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 June 2012 - 30 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Details on strain: Wistar / Crl:WI (Han) SPF
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks (males) and 13 weeks (females), respectively
- Weight at study initiation: mean (males): 273.0 ± 6.63g; mean (females): 225.8 ± 3.19g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III
- Diet (ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (ad libitum): Tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

deionized water

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: about 40 cm² (corresponds to at least 10% of the body surface)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.71 mL/kg bw
- Concentration (if solution): 35 g/100 mL
- Constant volume or concentration used: yes
- For solids, paste formed: no
- Form of application: solution in deionized water
- Test item preparation and homogenization: For better handling the test item was ground with mortar and pestle. The test item preparation was produced shortly before application by stirring with a magnetic stirrer.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.

Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.
The evaluation of skin reactions was performed according to Draize, J.H. (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.

Body weight: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.

Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No systemic clinical signs were observed during clinical examination.

Body weight:

Males:
The mean body weight of the male animals increased within the normal range throughout the study period.

Females:
The mean body weight of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of observation period.

Other findings:

Local effects:
No local effects were observed.

Body weight changes:

Individual body weight changes
Dose [mg/kg bw]	2000
Sex	male
Animal No.	1	2	3	4	5	mean	sd.
Body weight at study day [g]
0	274	267	282	266	276	273.0	6.63
7	278	284	301	281	285	285.8	8.93
14	307	304	330	299	308	309.6	11.93

 

Individual body weight changes
Dose [mg/kg bw]	2000
Sex	female
Animal No.	1	2	3	4	5	mean	sd.
Body weight at study day [g]
0	224	222	230	225	228	225.8	3.19
7	231	220	234	226	230	228.2	5.40
14	237	238	240	239	238	238.4	1.14

sd. = standard deviation

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The whole data base is conclusive and of high quality.

Additional information

There are no data on acute oral and dermal toxicity available for C16-20 AS Na (CAS 91648-55-4). 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 category show structural similarity. The most important common structural feature of the category members 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 members of the AS category in turn represent the predominant attribute in mediating effects on mammalian health. Therefore, the AS of the AS category have similar physicochemical, environmental and toxicological properties, validating the read across approach within the category. 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 program carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

 

Acute oral toxicity

Regarding the acute oral toxicity one relevant key study is available for the read-across substance C12-18AS Na (CAS 68955-19-1) and two supporting studies for C16-18 AS Na (CAS 68955-20-4).

One acute oral toxicity study was conducted with C12-18AS Na (CAS 68955-19-1, analytical purity 25%) on Cox CD rats (P&G, 1974). The test substance was applied to 10 animals per sex per group at doses of 2500, 3500, 4900 and 6850 mg/kg bw via gavage. The post observation period comprised 14 days. Following mortalities were observed within the different dose groups: 0/10, 5/10, 6/10 and 10/10. Clinical signs of toxicity comprised of slight to moderate decreased motor activity and respiratory rate, blanching, abdominal griping and diarrhea at 2500 mg/kg bw, slight haemorrhagic rhinitis which persisted up to seven days post treatment at 3500 and 4900 mg/kg bw and of slight loss of corneal reflex and pupillary responses at 6850 mg/kg bw. No findings were observed upon necropsy. The LD50 was given as 4010 mg/kg bw based on the active ingredient in the study report.

A second acute oral toxicity study was conducted with C16-18 AS Na (CAS 68955-20-4, analytical purity 55%) similar to OECD guideline 401 as a limit test at 2000 mg/kg bw on 5 Wistar rats per sex per dose (BASF, 1987a). The animals were treated via gavage and the post observation period comprised of 14 days. No mortalities occurred. Clinical signs of toxicity comprised of decreased motility in males and salivation after dosing. Upon necropsy no treatment related findings were observed. Thus, the LD50 was greater than 2000 mg/kg bw based on the test substance and greater than 1100 mg/kg bw based on the active ingredient.

A further acute oral toxicity study was conducted with C16-18 AS Na (CAS 68955-20-4, analytical purity 94.3%) according to OECD guideline 401 presumably as a limit test at 2000 mg/kg bw on 10 Wistar rats per sex per dose (BASF, 1995a). Only limited data on the experimental phase are available. No route of application was given but the volume administered was 10 mL/kg bw indicating an application via gavage. The LD50 within this study was greater 2000 mg/kg bw based on the test substance and although the analytical purity is above 94% this was calculated based on active ingredient to yield an LD50 greater 1886 mg/kg bw.

In conclusion the data justify a non-classification of C16-20 AS Na (CAS 91648-55-4) for oral acute toxicity.

 

Acute dermal toxicity

Regarding the acute dermal toxicity one key and three supporting studies are available for relevant read-across substances.

The key study was conducted with C8 AS Na (CAS 142-31-4) according to OECD Guideline 402 (BASF, 2012a). 5 Wistar rats per sex were treated with 2000 mg/kg bw under semi occlusive conditions for 24 h. No mortality occurred, no sign of systemic toxicity and of local irritation was observed.

The study conducted with C10-16 AS NH4 (CAS 68081-96-9) was performed as limit test conducted similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (P&G, 1975a). The test substance (analytical purity 25.1%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Clinical signs of toxicity comprised of severe erythema and slight eschar formation at 24 h, necrosis by day 2–14 with sloughing of the skin by day 8–14 and hyper-pigmentation of new skin by day 14. No signs of systemic toxicity were observed. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater than 500 mg/kg bw based on the active ingredient.

The study conducted with C10-16AS Mg (CAS 68081-97-0) was performed as limit test conducted similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (P&G, 1975b). The test substance (analytical purity 23.5%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Clinical signs of toxicity comprised of severe erythema and eschar formation at 24 h, necrosis by Day 5–21 and necrotic tissues sloughed and leaving skin hyper-pigmented at Day 21. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

Another study similar to OECD Guideline 402 was performed with C12-13 AS K (CAS 91783-22-1) on three male and three female New Zealand White rabbits (P&G, 1978a). Both sexes were dosed at 2000 mg/kg bw (analytical purity 25%) under occlusive conditions for 24 h. No mortalities occurred during the conduct of the study. Findings within this study comprised of moderate to severe erythema, edema, and atonia, desquamation and fissuring by day 6 and eschar formation and exfoliation. Based on the above mentioned findings the LD50 is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

Within the studies mentioned above no mortalities or signs of systemic toxicity occurred after dermal application of alkyl sulfates with varying carbon chain length. Taken into account the generally low toxicity after oral application and the low dermal absorption rate of alkyl sulfates (approx. 1%) this result was expected. In agreement, no classification for acute dermal toxicity is required. For details on absorption please see section Toxicokinetics, metabolism and distribution.

In conclusion the data justify a non-classification of C16-20 AS Na (CAS 91648-55-4) for dermal acute toxicity.

 

Acute inhalation toxicity

No studies for acute inhalation toxicity are available. However, testing the potential of acute toxicity via inhalation route of C16-20 AS Na (CAS 91648-55-4) is considered to be not justified. According to Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. As information under 8.5.3 (dermal route) is provided, the requirement is fulfilled by using the most appropriate route of exposure. 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). Taken into account that the acute toxicity of AS is generally low no further information on acute toxicity is expected by testing for acute inhalation toxicity as the predominant effect will comprise of local irritant effects rather than systemic toxicity.

 

[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

The available data on acute toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.