Sodium octane-1-sulphonate monohydrate

Endpoint summary

Description of key information

Repeat dose toxicity: oral; NOAEL = 5000 ppm (430 mg/kg bw/d); OECD 408; Walker et al. (1967) (Read-across)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH - Refer to Section 13.2 for read-across justification document

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Deviations:

not applicable

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

other: Carworth Farm 'E' strain

Details on species / strain selection:

Inhouse laboratory culture.
Pathogen-free.

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inhouse culture
- Females (if applicable) nulliparous and non-pregnant: Not reported
- Age at study initiation: 5 weeks
- Weight at study initiation: 150-250 g
- Fasting period before study: No
- Housing: Not reported
- Diet (e.g. ad libitum): Ad lib
- Water (e.g. ad libitum): Ad lib
- Acclimation period: Not reported

DETAILS OF FOOD AND WATER QUALITY: Diet = Diet 86 powder (Withers Ltd., Godalming, Surrey)

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

IN-LIFE DATES: From: To: Not reported

Route of administration:

oral: feed

Details on route of administration:

Rats were fed dietary levels of 40, 200, 1000 or 5000 ppm active material (corresponding to 3, 17, 86 and 430 mg/kg bw/day actual ingested) for 13 weeks. Control groups received Diet 86 powder (Withers Ltd., Godalruing, Surrey).

Vehicle:

not specified

Details on oral exposure:

- PREPARATION OF DOSING SOLUTIONS: Not reported

- DIET PREPARATION
- Rate of preparation of diet (frequency): Not reported
- Mixing appropriate amounts with (Type of food): Not reported
- Storage temperature of food: Not reported

- VEHICLE
- Justification for use and choice of vehicle (if other than water): Not reported
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): N/A
- Lot/batch no. (if required): Not reported
- Purity: Not reported

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

N/A

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

Diet provided ad libitum

Dose / conc.:

40 ppm

Dose / conc.:

200 ppm

Dose / conc.:

1 000 ppm

Dose / conc.:

5 000 ppm

No. of animals per sex per dose:

12 male and 12 female per test treatment group
18 male and 18 female per test Control group

Control animals:

yes, plain diet

Details on study design:

- Dose selection rationale: From previous literature (Smyth, Seaton & Fischer, 1941; Fitzhugh & Nelson, 1948; Fitzhugh, Schouboe & Nelson, 1960; Tusing, Paynter, Opdyke & Snyder, 1962).
- Rationale for animal assignment (if not random): Not reported
- Rationale for selecting satellite groups: N/A
- Post-exposure recovery period in satellite groups: N/A
- Section schedule rationale (if not random): N/A

Positive control:

N/A

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily

BODY WEIGHT: Yes
- Time schedule: Weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Mean weekly food intake per treatment group calculated

FOOD EFFICIENCY: No

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes (Haemoglobin, packed cell volume, red blood cell, white blood cell)
- Time schedule for collection of blood: Study terminus
- Anaesthetic used for blood collection: No
- Animals fasted: Not specified
- How many animals: 12 males and 12 females from each test group and 18 males and 18 females from control groups

CLINICAL CHEMISTRY: Yes (urea, protein)
- Time schedule for collection of blood: Study terminus
- Animals fasted: Not specified
- How many animals: 12 males and 12 females from each test group and 18 males and 18 females from control groups.

URINALYSIS: Yes (pH, osmolarity reported and colour, protein, reducing substances and bile salts found to be negative in all test groups)
- Time schedule for collection of urine: Week 12 for 5000 ppm and control groups only
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Not specified

NEUROBEHAVIOURAL EXAMINATION: No

IMMUNOLOGY: No

OTHER: N/A

Sacrifice and pathology:

GROSS PATHOLOGY: Yes, mean organ weights reported (brain (adjusted for initial body weight), heart, liver, spleen, kidneys, testes)

HISTOPATHOLOGY: Yes, sections of organs taken from control and 5000 ppm groups.

Other examinations:

N/A

Statistics:

Statistical analyses of terminal body weights, food intakes and organ weights were made using the initial body weight as a covariate in covariance analysis.

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

effects observed, non-treatment-related

Description (incidence and severity):

A statistically significant increse in Hb, PCV (p ≤ 0.05) and RBC (p ≤ 0.01) was observed in the blood samples collected from female rats treated with 40 ppm. In the absence of a dose response at higher test concentrations, the effects cannot be attributed to a test item related response.

Clinical biochemistry findings:

effects observed, non-treatment-related

Description (incidence and severity):

Increase serum urea concentration in females on 5000 ppm and increase in serum total concentration in males on 5000 ppm

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Immunological findings:

not examined

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Description (incidence and severity):

Significant increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significantly (p ≤ 0.05)

Gross pathological findings:

no effects observed

Neuropathological findings:

not examined

Histopathological findings: non-neoplastic:

effects observed, non-treatment-related

Description (incidence and severity):

Spontaneous lesions, mainly hydronephrosis, were present in all groups of animals.

Histopathological findings: neoplastic:

not examined

Other effects:

not examined

Details on results:

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significantly (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) were unaccompanied by any pathological effects, as a result, 5000 ppm is considered a no-observed effect level (NOAEL) for the test item.

Dose descriptor:

NOAEL

Effect level:

5 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

organ weights and organ / body weight ratios

Key result

Dose descriptor:

NOAEL

Effect level:

> 430 mg/kg bw/day (actual dose received)

Based on:

test mat.

Remarks:

actual dose received

Sex:

male/female

Basis for effect level:

organ weights and organ / body weight ratios

Critical effects observed:

no

Table 3       Mean body weights and body weight gains/ losses

 

Dietary intake (ppm)	Male				Female
	Body weight (g) at week			Mean weekly food intake (g)	Body weight (g) at week			Mean weekly food intake (g)
	4	8	13		4	8	13
0	243	319	359	139	172	213	227	107
40	246	323	363	140	175	215	233	108
200	239	315	348	138	170	213	225	104
1000	234	308	351	133	175	216	228	111
5000	243	319	365	139	169	213	226	106

Body weights are adjusted for initial body weight

For test groups (n=12) and for control groups (n=18)

 

Table 4       Mean haematological examination results

 

Dietary intake (ppm)	Male				Female
	Hb (g/100 mL)	PCV (%)	RBC (10^8/mm^8)	WBC (10^8/mm^8)	Hb (g/100 mL)	PCV (%)	RBC (10^8/mm^8)	WBC (10^8/mm^8)
0	14.4	46.2	-	-	14.1	42.8	6.52	4.8
40	14.5	46.0	-	-	14.7*	45.3*	7.01**	4.9
200	14.5	47.4	-	-	14.1	45.3	6.77	4.6
1000	14.6	46.6	-	-	13.7	41.9	6.47	4.0
5000	14.5	46.1	-	-	14.6	43.7	6.74	4.5

Hb (haemoglobin); PCV (packed cell volume); RBC (red blood cell); WBC (white blood cell)

- RBC and WBC for males was disregarded due to a fault with the measuring device

For test groups (n=12) and for control groups (n=18)

* (p ≤0 0.05); ** (p ≤ 0.01)

 

Table 5       Mean serum chemistry and urine analysis

 

Dietary intake (ppm)	Male				Female
	Serum chemistry		Urine analysis		Serum chemistry		Urine analysis
	Urea (g/100 mL)	Protein (g/100 mL)	pH	Osmolarity (mosmoles)	Urea (g/100 mL)	Protein (g/100 mL)	pH	Osmolarity (mosmoles)
0	52	6.4	7.1	2003	56	6.3	6.3	1840
40	51	6.3	-	-	58	6.2	-	-
200	53	6.2	-	-	54	6.2	-	-
1000	53	6.2	-	-	60	6.0	-	-
5000	54	6.3	6.7	2054	53	6.5	6.2	1870

Test for blood, bile salts and reducing substances were negative in all groups

- Not examined

For test groups (n=12) and for control groups (n=18)

 

Table 6       Absolute organ weights (g)

 

Dietary intake (ppm)	Male							Female
	B.W.	Brain	Heart	Liver	Spleen	Kidneys	Testes	B.W.	Brain	Heart	Liver	Spleen	Kidneys
0	359	1.96	0.98	13.71	0.66	2.40	3.51	228	1.86	0.70	8.53	0.50	1.55
40	363	1.96	0.98	13.02	0.67	2.43	3.45	233	1.88	0.72	7.82	0.50	1.60
200	348	1.95	0.96	12.85	0.66	2.31	3.47	225	1.84	0.68	8.62	0.51	1.58
1000	351	1.97	0.98	13.33	0.68	2.34	3.42	228	1.88	0.67	8.24	0.50	1.57
5000	365	1.98	0.98	13.70	0.66	2.34	3.48	226	1.83	0.70	9.30*	0.51	1.59

Values are means, except brain, adjusted for initial body weight of groups of 12 test and 18 control animals

B.W. (terminal body weight)

* (p ≤ 0.05)

Conclusions:

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) was unaccompanied by any pathological effects, as a result, 5000 ppm is considered a no-observed effect level (NOAEL) for the test item.

This result is appropriate under a read-across approach for applicability to the target substance sodium octane-1-sulphonate monohydrate.

Executive summary:

The purpose of this test was to assess the systemic toxicity potential of sodium lauryl sulphate following repeated exposure to 12 male and 12 female Carwoth Farm ‘E’ strain in rats by dietary administration at dose levels of 40, 200, 1000 and 5000 ppm for up to 13 weeks.

 

A summary of adult responses to the test item are described below;

 

Mortality- no treatment related effects were observed.

 

Clinical signs- no treatment related effects were observed.

 

Bodyweight- no treatment related effects were observed.

 

Food consumption and efficiency- no treatment related effects were observed.

 

Haematology and urinalysis-no treatment related effects were observed

 

Organ weights- Significant increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05).

 

Histopathology- The increase in organ weights at the highest tested concentration (5000 ppm) were unaccompanied by any pathological effects.

 

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm (corresponding to 3, 17, 86 and 430 mg/kg bw/day actual ingested) had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) was unaccompanied by any pathological effects, as a result, 5000 ppm (430 mg/kg bw/d) is considered a no-observed effect level (NOAEL) for the test item.

Reference 2

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See document attached in Section 13.2 for analogue read-across justification.

Reason / purpose for cross-reference:

read-across source

Histopathological findings: non-neoplastic:

effects observed, non-treatment-related

Dose descriptor:

NOAEL

Effect level:

5 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

organ weights and organ / body weight ratios

Key result

Dose descriptor:

NOAEL

Effect level:

> 430 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

organ weights and organ / body weight ratios

Critical effects observed:

no

Conclusions:

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) was unaccompanied by any pathological effects, as a result, 5000 ppm is considered a no-observed effect level (NOAEL) for the test item.

Executive summary:

See document attached in Section 13.2 for analogue read-across justification.

The purpose of this test was to assess the systemic toxicity potential of sodium lauryl sulphate following repeated exposure to 12 male and 12 female Carwoth Farm ‘E’ strain in rats by dietary administration at dose levels of 40, 200, 1000 and 5000 ppm for up to 13 weeks.

 

A summary of adult responses to the test item are described below;

 

Mortality- no treatment related effects were observed.

 

Clinical signs- no treatment related effects were observed.

 

Bodyweight- no treatment related effects were observed.

 

Food consumption and efficiency- no treatment related effects were observed.

 

Haematology and urinalysis-no treatment related effects were observed

 

Organ weights- Significant increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05).

 

Histopathology- The increase in organ weights at the highest tested concentration (5000 ppm) were unaccompanied by any pathological effects.

 

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) were unaccompanied by any pathological effects, as a result, 5000 ppm (430 mg/kg bw/d) is considered a no-observed effect level (NOAEL) for the test item.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

430 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

The endpoint is concluded based on a single read across study with a Klimish rating of 2.

System:

other: The NOAEL was derived from the highest tested concentration (5000 ppm), where no adverse effects on the rat were observed.

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.6.1, Column 2 and supporting ECHA Guidance, concerning repeated dose toxicity testing, the oral route is the default one because it is assumed to maximise systemic availability (internal dose). There was no evidence available to support the use of an alternative route for this study.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.6.1, Column 2 and supporting ECHA Guidance, concerning repeated dose toxicity testing, the oral route is the default one because it is assumed to maximise systemic availability (internal dose). There was no evidence available to support the use of an alternative route for this study.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.6.1, Column 2 and supporting ECHA Guidance, concerning repeated dose toxicity testing, the oral route is the default one because it is assumed to maximise systemic availability (internal dose). There was no evidence available to support the use of an alternative route for this study.

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.6.1, Column 2 and supporting ECHA Guidance, concerning repeated dose toxicity testing, the oral route is the default one because it is assumed to maximise systemic availability (internal dose). There was no evidence available to support the use of an alternative route for this study.

Endpoint conclusion

Endpoint conclusion:

no study available

Mode of Action Analysis / Human Relevance Framework

No adverse effects were observed at the highest tested concentration (5000 ppm; 430 mg/kg bw/d).

Additional information

See document attached in Section 13.2 for analogue read-across justification.

OECD 408 - The purpose of this test was to assess the systemic toxicity potential of sodium lauryl sulphate following repeated exposure to 12 male and 12 female Carworth Farm ‘E’ strain in rats by dietary administration at dose levels of 40, 200, 1000 and 5000 ppm for up to 13 weeks.

 

A summary of adult responses to the test item are described below;

 

Mortality- no treatment related effects were observed.

 

Clinical signs- no treatment related effects were observed.

 

Bodyweight- no treatment related effects were observed.

 

Food consumption and efficiency- no treatment related effects were observed.

 

Haematology and urinalysis-no treatment related effects were observed

 

Organ weights- Significant increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05).

 

Histopathology- The increase in organ weights at the highest tested concentration (5000 ppm) were unaccompanied by any pathological effects.

 

In conclusion, treatment with the test item at 40, 200, 1000 and 5000 ppm had no definite effect on mortality, clinical condition, body weight gain, feeding, haematology or urinalysis. Increases in absolute organ weights were confined to the highest test group (5000 ppm) however only the increased liver weights from the females were found to be statistically significant (p ≤ 0.05). The increase in organ weights at the highest tested concentration (5000 ppm) was unaccompanied by any pathological effects, as a result, 5000 ppm (430 mg/kg bw/d) is considered a no-observed effect level (NOAEL) for the test item.

Justification for classification or non-classification

The substance does not meet the criteria for classification in accordance with Regulation (EC) No 1272/2008 (CLP).