Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

supporting study

Cross-reference

Cross-reference 1

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

no

Limit test:

no

Species:

mouse

Strain:

CD-1

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

VEHICLE
- Concentration in vehicle: no data

Details on mating procedure:

no further specified

Duration of treatment / exposure:

day 6 - 15 of gestation

Frequency of treatment:

daily

Duration of test:

sacrifice at day 17 of gestation

Dose / conc.:

0.2 mg/kg bw/day (actual dose received)

Dose / conc.:

2 mg/kg bw/day (actual dose received)

Dose / conc.:

300 mg/kg bw/day (actual dose received)

Dose / conc.:

600 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

20

Control animals:

yes, concurrent vehicle

Maternal examinations:

-Clinical observations:
Animals were observed daily for signs of toxicity and were weighed regularly throughout gestation.
- Organs examined at necropsy (macroscopic and microscopic):
All animals, including those that died during the study, were dissected and examined for macroscopic changes immediately after sacrifice.

Ovaries and uterine content:

Uteri were dissected and the contents examined to determine the numbers of implantations, viable young and embryonic deaths.

Fetal examinations:

Fetuses were examined for visceral anomalies, or dissected and examined followed by clearing, alizarin staining and skeletal examination.

Statistics:

Wilcoxon test

Description (incidence):

300 mg/kg: mortality 1/20
600 mg/kg: mortality 4/20

Dose descriptor:

NOAEL

Remarks:

maternal toxicity

Effect level:

ca. 2 mg/kg bw/day (actual dose received)

Basis for effect level:

other: no effects observed

Dose descriptor:

LOAEL

Remarks:

maternal toxicity

Effect level:

ca. 300 mg/kg bw/day (actual dose received)

Basis for effect level:

mortality

Description (incidence and severity):

<= 300 mg/kg: no adverse effects on foetal morphogenesis
600 mg/kg: total resorption and/or increased incidence of litter loss

Key result

Dose descriptor:

NOAEL

Remarks:

teratogenicity

Effect level:

ca. 300 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: resorption

Key result

Abnormalities:

no effects observed

Key result

Developmental effects observed:

no

Lowest effective dose / conc.:

300 mg/kg bw/day

Treatment related:

yes

Observation	Dose (mg/kg bw)
	0	0.2	2	300	600
mated	20	20	20	20	20
died	0	0	0	1	4
non-pregnant	2	2	3	4	2
total litter loss	0	2	2	2	4
With viable young	18	16	15	13	10

Conclusions:

Under the present test conditions the following effect levels were established:
NOAEL maternal toxicity= 2 mg/kg bw
NOAEL teratogenicity= 300 mg/kg bw
LOAEL maternal toxicity = 300 mg/kg bw

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.

Sodium dodecyl sulphate was administered to 20 female CD-1 mice per dose group.

The mice were dosed by gavage with water as vehicle once daily at 0, 0.2, 2, 300 or 600 mg /kg bw/d from days 6- 15 of gestation.

The animals were observed daily for signs of toxicity and were weighed regularly throughout gestation and were sacrificed at day 17 of gestation.

All animals, including those that died during the study, were dissected and examined for macroscopic changes immediately after sacrifice.

Uteri were dissected and the contents examined to determine the numbers of implantations, viable young and embryonic deaths.

Fetuses were examined for visceral anomalies, or dissected and examined followed by clearing, alizarin staining and skeletal examination.

Viable young were weighed and examined for external abnormalities.

 

Maternal data:

300 mg/kg: mortality 1/20

600 mg/kg: mortality 4/20

 

Offspring:

<= 300 mg/kg: no adverse effects on foetal morphogenesis

600 mg/kg: total resorption and/or increased incidence of litter loss

 

The following effect levels were established:

NOAEL maternal toxicity= 2 mg/kg bw

NOAEL teratogenicity= 300 mg/kg bw

LOAEL maternal toxicity = 300 mg/kg bw

 

Reference:

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part I - LAS, AS and CLD. Toxicology 3, 91 - 106

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part II - AOS. Toxicology 3, 107 – 113

Cross-reference 2

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

other: CD

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
-Total volume applied: no data

VEHICLE
- Concentration in vehicle: no data

Details on mating procedure:

no further specified

Duration of treatment / exposure:

day 6 - 15 of gestation

Frequency of treatment:

daily

Duration of test:

sacrifice at day 20 of gestation

Dose / conc.:

0.2 mg/kg bw/day (actual dose received)

Dose / conc.:

2 mg/kg bw/day (actual dose received)

Dose / conc.:

300 mg/kg bw/day (actual dose received)

Dose / conc.:

600 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

20

Control animals:

yes, concurrent vehicle

Maternal examinations:

-Clinical observations:
Animals were observed daily for signs of toxicity and were weighed regularly throughout gestation.
- Organs examined at necropsy (macroscopic and microscopic):
All animals, including those that died during the study, were dissected and examined for macroscopic changes immediately after sacrifice.

Ovaries and uterine content:

Uteri were dissected and the contents examined to determine the numbers of implantations, viable young and embryonic deaths. Ovaries were examined and the number of corpora lutea were counted.

Fetal examinations:

Viable young were weighed and examined for external abnormalities.
Fetuses were examined for visceral anomalies, or dissected and examined followed by clearing, alizarin staining and skeletal examination.

Statistics:

Wilcoxon test

Description (incidence and severity):

>= 300 mg/kg: slight to moderate toxicity (anorexia, weight loss, cachexia, abortion)

Description (incidence):

600 mg/kg: mortality 3/20

Description (incidence and severity):

>= 300 mg/kg: slight to moderate toxicity (abortion)

Dose descriptor:

NOAEL

Remarks:

maternal toxicity

Effect level:

ca. 2 mg/kg bw/day (actual dose received)

Basis for effect level:

other: no effects observed

Dose descriptor:

LOAEL

Remarks:

maternal toxicity

Effect level:

ca. 300 mg/kg bw/day (actual dose received)

Basis for effect level:

number of abortions

Details on embryotoxic / teratogenic effects:

600 mg/kg: no adverse effects

Key result

Dose descriptor:

NOAEL

Remarks:

teratogenicity

Effect level:

ca. 600 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

changes in sex ratio

fetal/pup body weight changes

changes in litter size and weights

external malformations

skeletal malformations

visceral malformations

Key result

Abnormalities:

no effects observed

Key result

Developmental effects observed:

no

Lowest effective dose / conc.:

600 mg/kg bw/day

Treatment related:

yes

Observation	Dose (mg/kg bw)
	0	0.2	2	300	600
mated	20	20	20	20	20
died	0	0	0	0	3
non-pregnant	3	1	2	1	0
total litter loss	0	0	0	0	0
With viable young	17	19	18	19	17

Conclusions:

Under the present test conditions the following effect levels were established:
NOAEL maternal toxicity= 2 mg/kg bw
NOAEL teratogenicity= 600 mg/kg bw
LOAEL maternal toxicity = 300 mg/kg bw

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.

Sodium dodecyl sulphate was administered to 20 female CD rats per dose group.

The rats were dosed by gavage with water as vehicle once daily at 0, 0.2, 2, 300 or 600 mg /kg bw/d from days 6- 15 of gestation.

The animals were observed daily for signs of toxicity and were weighed regularly throughout gestation and were sacrificed at day 20 of gestation.

All animals, including those that died during the study, were dissected and examined for macroscopic changes immediately after sacrifice.

Uteri were dissected and the contents examined to determine the numbers of implantations, viable young and embryonic deaths.

Ovaries were examined and the number of corpora lutea were counted.

Fetuses were examined for visceral anomalies, or dissected and examined followed by clearing, alizarin staining and skeletal examination.

Viable young were weighed and examined for external abnormalities.

 

Maternal data:

>= 300 mg/kg: slight to moderate toxicity (anorexia, weight loss, cachexia, abortion)

600 mg/kg: mortality 3/20

 

Offspring:

600 mg/kg: no adverse effects

 

The following effect levels were established:

NOAEL maternal toxicity= 2 mg/kg bw

NOAEL teratogenicity= 600 mg/kg bw

LOAEL maternal toxicity = 300 mg/kg bw

 

Reference:

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part I - LAS, AS and CLD. Toxicology 3, 91 - 106

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part II - AOS. Toxicology 3, 107 - 113

Cross-reference 3

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

13 animals/group

GLP compliance:

no

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

VEHICLE
- Concentration in vehicle: no data

Duration of treatment / exposure:

day 6 - 18 of gestation

Frequency of treatment:

daily

Duration of test:

sacrifice at day 29 of gestation

Dose / conc.:

0.2 mg/kg bw/day (actual dose received)

Dose / conc.:

2 mg/kg bw/day (actual dose received)

Dose / conc.:

300 mg/kg bw/day (actual dose received)

Dose / conc.:

600 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

13

Control animals:

yes, concurrent vehicle

Description (incidence and severity):

>= 300 mg/kg: diarrhoea, anorexia, cachexia,

Description (incidence):

300 mg/kg: mortality 1/13
600 mg/kg: mortality 11/13

Description (incidence and severity):

>= 300 mg/kg: weight loss

Details on maternal toxic effects:

>= 300 mg/kg: foetal loss

Dose descriptor:

NOAEL

Remarks:

maternal toxicity

Effect level:

ca. 2 mg/kg bw/day (actual dose received)

Basis for effect level:

other: no effects observed

Dose descriptor:

LOAEL

Remarks:

maternal toxicity

Effect level:

ca. 300 mg/kg bw/day (actual dose received)

Basis for effect level:

body weight and weight gain

mortality

Details on embryotoxic / teratogenic effects:

<= 300 mg/kg: no adverse effects on foetal morphogenesis
600 mg/kg: abortion, total resorption and/or increased incidence of litter loss

Key result

Dose descriptor:

NOAEL

Remarks:

teratogenicity

Effect level:

ca. 300 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

changes in sex ratio

fetal/pup body weight changes

changes in litter size and weights

external malformations

skeletal malformations

visceral malformations

Key result

Abnormalities:

effects observed, treatment-related

Localisation:

other: not specified

Key result

Developmental effects observed:

no

Lowest effective dose / conc.:

600 mg/kg bw/day

Treatment related:

yes

Observation	Dose (mg/kg bw)
	0	0.2	2	300	600
mated	13	13	13	13	13
died	2	0	1*	1	11
non-pregnant	1	1	2	1	0
total litter loss	0	1	0	2	0
With viable young	10	11	10	9	2

* intubation error

Conclusions:

Under the present test conditions the following effect levels were established:
NOAEL maternal toxicity= 2 mg/kg bw
NOAEL teratogenicity= 300 mg/kg bw
LOAEL maternal toxicity = 300 mg/kg bw

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.

Sodium dodecyl sulphate was administered to 13 female New Zealand White rabbits per dose group.

The rabbits were dosed by gavage with water as vehicle once daily at 0, 0.2, 2, 300 or 600 mg /kg bw/d from days 6- 18 of gestation.

The animals were observed daily for signs of toxicity and were weighed regularly throughout gestation and were sacrificed at day 29 of gestation.

All animals, including those that died during the study, were dissected and examined for macroscopic changes immediately after sacrifice.

Uteri were dissected and the contents examined to determine the numbers of implantations, viable young and embryonic deaths.

Ovaries were examined and the number of corpora lutea were counted.

Fetuses then were dissected and examined for abnormalities of internal organs, sex determination, and clearing, alizarin staining and skeletal examination.

Viable young were weighed and examined for external abnormalities.

 

Maternal data:

300 mg/kg: mortality 1/13

>= 300 mg/kg: diarrhoea, anorexia, weight loss, cachexia, foetal loss

600 mg/kg: mortality 11/13

 

Offspring:

<= 300 mg/kg: no adverse effects on foetal morphogenesis

600 mg/kg: abortion, total resorption and/or increased incidence of litter loss

 

The following effect levels were established:

NOAEL maternal toxicity= 2 mg/kg bw

NOAEL teratogenicity= 300 mg/kg bw

LOAEL maternal toxicity = 300 mg/kg bw

 

Reference:

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part I - LAS, AS and CLD. Toxicology 3, 91 - 106

-Palmer AK, Readshaw MA & Neuff AM (1975) Assessment of the teratogenic potential of surfactants. Part II - AOS. Toxicology 3, 107 – 113

Cross-reference 4

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

15 animals/group (10 for dissection, 5 for natural parturition)

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 16 - 18 weeks

Route of administration:

oral: gavage

Vehicle:

not specified

Details on mating procedure:

Virgin female rats were taken at random from a stock cage and recaged in groups of 3 with each of 15 virgin male rats of the same age and from the same colony. The dropping trays were examined each morning thereafter for ejected vaginal plugs, and when these were found the female rats were removed and individually examined for evidence of mating. Confirmation of mating was established by microscopically examination of the vaginal mucus for the presence of spermatozoa.

Duration of treatment / exposure:

days 6 - 15 of gestation

Frequency of treatment:

once daily

Duration of test:

termination on day 21 of gestation or up to weaning day 21

Dose / conc.:

63 mg/kg bw/day (actual dose received)

Remarks:

test substance

Dose / conc.:

125 mg/kg bw/day (actual dose received)

Remarks:

test substance

Dose / conc.:

250 mg/kg bw/day (actual dose received)

Remarks:

test substance

Dose / conc.:

500 mg/kg bw/day (actual dose received)

Remarks:

test substance

No. of animals per sex per dose:

15 rats per dose group (10 for dissection, 5 for natural parturition)

Control animals:

yes

Maternal examinations:

-body weight: daily
-maternal food intake: daily

Ovaries and uterine content:

-mean gravid uterus weight & mean weight of uterine tissue; intrauterine mortality; mean response per pregnancy; mean foetal body weight, crown rump distance and mean placental weight; % incidence of external and gross visceral observations of foetuses; incidence of skeletal variants/anomalies of foetuses; incidence and distribution of other anomalies;

Fetal examinations:

post-partum mortalities; mean body weight of pups (at birth and on days 7, 14 and 21); weaned of born; incidence of external and gross visceral variations of pups; incidence of skeletal variations of pups

Description (incidence and severity):

All animals at 500 mg/kg had diarrhoea, which continued until cessation of treatment. With successive treatments the passage of the cannula down the oesophagus became more difficult suggesting a dryness of the membranes, and the demeanour of the animals became more aggressive. Between the 4th and 8th dose 4 of the animals of this group died and 1 was killed because of its condition. A further animal aborted on the 14th day of gestation having received 9 treatments. All the animals which died showed evidence of gastrointestinal irritation and diffuse haemorrhage of the stomach. In 3 instances there was also congestion of the lungs.

Description (incidence):

Between the 4th and 8th dose 4 of the animals of the 500 mg/kg dose group died and 1 was killed because of its condition.

Description (incidence and severity):

Treatment with 500 mg/kg induced a significant (p = < 0.05) reduction in maternal body weight gain during the period of treatment.

Description (incidence and severity):

Rats treated with 500 mg/kg consumed significantly (p=<0.05) less food than controls.

Description (incidence and severity):

Treatment did not adversely affect the pre- or post-implantation loss.

Description (incidence and severity):

Intrauterine mortality: No significant differences between treatment and control

Dose descriptor:

NOAEL

Remarks:

maternal toxicity

Effect level:

ca. 250 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: no effects observed

Dose descriptor:

LOAEL

Remarks:

maternal toxicity

Effect level:

ca. 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

body weight and weight gain

gross pathology

other: placental weight

Key result

Dose descriptor:

NOAEL

Remarks:

teratogenicity

Effect level:

ca. 500 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

changes in sex ratio

fetal/pup body weight changes

changes in litter size and weights

external malformations

skeletal malformations

visceral malformations

Key result

Abnormalities:

no effects observed

Key result

Developmental effects observed:

no

Lowest effective dose / conc.:

500 mg/kg bw/day

Treatment related:

yes

Maternal data

General health:

All animals at 500 mg/kg had diarrhoea, which continued until cessation of treatment. With successive treatments the passage of the cannula down the oesophagus became more difficult suggesting a dryness of the membranes, and the demeanour of the animals became more aggressive. Between the 4th and 8th dose 4 of the animals of this group died and 1 was killed because of its condition. A further animal aborted on the 14th day of gestation having received 9 treatments. All the animals which died showed evidence of gastrointestinal irritation and diffuse haemorrhage of the stomach. In 3 instances there was also congestion of the lungs.

Mean maternal body weight gain:

Treatment with 500 mg/kg induced a significant (p = < 0.05) reduction in maternal body weight gain during the period of treatment.

Food consumption:

Rats treated with 500 mg/kg consumed significantly (p=<0.05) less food than controls

Intrauterine mortality:

No significant differences between treatment and control

Mean response per pregnancy:

Treatment did not adversely affect the pre- or post-implantation loss

 

Offspring:

Foetal and placental size:

The mean placental weight for male and female foetuses combined and considered separately were significantly lower in animals fed 500 mg/kg (p= 0.05).

Incidence of gross variants/anomalies:

No significant differences between treatment groups and control group

Incidence of skeletal anomalies:

No significant differences between treatment groups and control group

Incidence of foetal variations, minor anomalies and major malformations:

Malformations were found in 3 foetuses from dams treated with 500 mg/kg - protruding tongue, gross oedema and shortening of the pubic bone; agenesis of eyelids and cleft palate; unossified metatarsus and claw in left hind foot. The foetuses were all taken from separate pregnancies. A single live foetus with a malformation was also found after treatment with 250 mg/kg (hermi-centric lumbar centra with asymmetry and reduced ossification of the 6th lumbar arch and scoliosis) and 63 mg/kg (unossified and dumbbell shaped thoracic centrae associated with branched ribs)

 

Rats allocated to natural parturition:

Post-partum mortalities:

No significant differences between treatment and controls.

Incidence of skeletal defects in rat pups:

No significant differences between treatment groups and control group.

Conclusions:

Under the present test conditions the following effect levels were established:
NOAEL maternal toxicity= 250 mg/kg bw
NOAEL teratogenicity= 500 mg/kg bw
LOAEL maternal toxicity = 500 mg/kg bw

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.

Sodium dodecyl sulphate was administered to 15 female Wistar rats per dose group (10 for dissection, 5 for natural parturition). The rats were dosed by gavage once daily at 0, 63, 125, 250 or 500 mg test substance/kg bw/d from days 6- 15 of gestation.

The following observations were performed:

-body weight: daily

-maternal food intake: daily

-mean gravid uterus weight & mean weight of uterine tissue; intrauterine mortality; mean response per pregnancy; mean foetal body weight, crown rump distance and mean placental weight; % incidence of external and gross visceral observations of foetuses; incidence of skeletal variants/anomalies of foetuses; incidence and distribution of other anomalies; post-partum mortalities; mean body weight of pups (at birth and on days 7, 14 and 21); weaned of born; incidence of external and gross visceral variations of pups; incidence of skeletal variations of pups

All maternal animals at 500 mg/kg had diarrhoea, which continued until cessation of treatment. With successive treatments the passage of the cannula down the oesophagus became more difficult suggesting a dryness of the membranes, and the demeanour of the animals became more aggressive. Between the 4th and 8th dose 4 of the animals of this group died and 1 was killed because of its condition. A further animal aborted on the 14th day of gestation having received 9 treatments. All the animals which died showed evidence of gastrointestinal irritation and diffuse haemorrhage of the stomach. In 3 instances there was also congestion of the lungs.

Treatment with 500 mg/kg induced a significant (p = < 0.05) reduction in maternal body weight gain during the period of treatment.

Rats treated with 500 mg/kg consumed significantly (p=<0.05) less food than controls.

No significant differences in intrauterine mortality were observed between treatment and control animals.

Treatment did not adversely affect the pre- or post-implantation loss.

 

The mean placental weight for male and female foetuses combined and considered separately were significantly lower in animals fed 500 mg/kg (p= 0.05).

No significant differences in incidence of gross variants/anomalies and skeletal anomalies between treatment groups and control group in the offspring.

Malformations were found in 3 foetuses from dams treated with 500 mg/kg: protruding tongue, gross oedema and shortening of the pubic bone; agenesis of eyelids and cleft palate; unossified metatarsus and claw in left hind foot. The foetuses were all taken from separate pregnancies. A single live foetus with a malformation was also found after treatment with 250 mg/kg (hermi-centric lumbar centra with asymmetry and reduced ossification of the 6th lumbar arch and scoliosis) and 63 mg/kg (unossified and dumbbell shaped thoracic centrae associated with branched ribs).

 

In the rats allocated to natural parturition, no significant differences in post-partum mortalities and incidence of skeletal defects in rat pups were observed between treatment and controls.

The following effect levels were established:

NOAEL maternal toxicity= 250 mg/kg bw

NOAEL teratogenicity= 500 mg/kg bw

LOAEL maternal toxicity = 500 mg/kg bw

 

Reference: Unilever Research (1976) Mutagenicity and teratology of alternative surfactants. IV. Teratology of sodium lauryl sulphate: oral administration in the rat (Unpublished Report No. PCW 76 1593). Unilever Research, Colworth/Welwyn. 70 pp.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols

EC Number:

944-399-8

Cas Number:

not yet assigned

Molecular formula:

see information in structural formula

IUPAC Name:

Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols

Applicant's summary and conclusion

Conclusions:

When the NOAEL of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008) from NOAEL values of the components (C16 and C18 LCOH; C12 AS as worst case), this resulted in an oral reproductive NOAEL of 1200 mg/kg bw in rats. It can therefore be concluded that the oral reproductive NOAEL of the registered substance is 1200 mg/kg bw.

Executive summary:

When the NOAEL of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008) from NOAEL values of the components (C16 and C18 LCOH; C12 AS as worst case), this resulted in an oral reproductive NOAEL of 1200 mg/kg bw in rats. It can therefore be concluded that the oral reproductive NOAEL of the registered substance is 1200 mg/kg bw.