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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Repeated dose toxicity - oral: No key repeated dose toxicity study with the target substance is available. Data from the supporting substance LABS Na was used to cover this endpoint. In a 28days repeated dose toxicity, LABS Na was dosed in male and female Sprague-Dawley rats via oral gavage at doses up to 500 mg/kg bw/day. The NOAEL and LOAEL were set at 125 and 250 mg/kg bw/day, respectively. In the key chronic toxicity study, LABS Na was dosed daily via diet during 6 months. The NOAEL and LOAEL were set at 40 and 115 mg/kg bw/day, respectively.

Repeated dose toxicity - inhalation: No key repeated dose toxicity study via inhalation administration is available.

Repeated dose toxicity - dermal: No key repeated dose toxicity study via dermal administration is available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male and female rats were exposed to LABS Na via gavage daily for 28 days.
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
CAS number 69669-44-9
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
one month
Frequency of treatment:
daily
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
125 mg/kg bw/day (nominal)
Dose / conc.:
250 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
Information as cited in IPCS document. 12 animals per dose group.
Control animals:
yes, concurrent no treatment
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Diarrhea was observed in the 500 mg/kg group and soft stools were observed in the other 2 groups.
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Body weight gain was suppressed in all the male groups and in the female 500 mg/kg group.
Food efficiency:
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
Haematological examinations revealed no abnormalities.
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
Serum-biochemical examinations revealed several differences among the mid and high dose group compared to the control group.
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
The weight of the spleen and the heart significantly decreased in the male high dose group. In the female high dose group, the weight of the liver increased while the weight of the heart and thymus decreased.
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Histological findings of the liver revealed no abnormalities.
Histopathological findings: neoplastic:
not specified
Dose descriptor:
NOAEL
Effect level:
125 other: mg/kg bw d
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Serum-biochemical differences
Dose descriptor:
LOAEL
Effect level:
250 other: mg/kg bw d
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Serum-biochemical differences
Critical effects observed:
not specified
Conclusions:
The test substance is considered to have a NOAEL = 125 mg/kg bw/day; LOAEL = 250 mg/kg bw/day.
Executive summary:

Male and female rats were exposed to Na-LAS via gavage daily for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, heart, thymus) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively.

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male and female rats were exposed to LABS Na in the diet daily for 6 months.
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
C10-14 LAS, sodium salt (CAS #69669-44-9)
C 10 10.6%, C 11 34.1%, C 12 27.7%, C 13 19.0% C 14 8.7%;
average alkyl chain length = C11.8;
mean molecular weight: 345.8
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
six months
Frequency of treatment:
daily in feed
Dose / conc.:
40 mg/kg bw/day (nominal)
Remarks:
0.07%
Dose / conc.:
115 mg/kg bw/day (nominal)
Remarks:
0.2%
Dose / conc.:
340 mg/kg bw/day (nominal)
Remarks:
0.6%
Dose / conc.:
1 030 mg/kg bw/day (nominal)
Remarks:
1.8%
No. of animals per sex per dose:
Information as cited in IPCS document. 12 animals per dose group.
Control animals:
yes, concurrent no treatment
Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food efficiency:
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
The 1.8% group showed diarrhea, markedly suppressed growth, increased weight of the cecum, and remarkable degeneration of the renal tubes. the 0.6% group showed slightly suppressed growth, increased weight of the cecum, increased activity of serum alkaline phosphatase (ALP), a decrease in serum protein and degeneration of the renal tubes. The 0.2% group showed increased weight of the cecum and slight degeneration of the renal tubes. The 0.07% group showed no adverse effects related to the administration of LAS. The intake of LAS in the 0.07% group was about 40 mg/kg bw/d.
Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: increased weight of the cecum and slight degeneration of the renal tubes
Dose descriptor:
LOAEL
Effect level:
115 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: increased weight of the cecum and slight degeneration of the renal tubes
Critical effects observed:
not specified
Conclusions:
The test substance is considered have an NOAEL = 40 mg/kg bw/day; LOAEL = 115 mg/kg bw/day. Therefore the substance should not be classified as STOT RE.
Executive summary:

Male and female rats were exposed to Na-LAS in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight, and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LAS. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study.

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
the original report was not available for review. However, the study was evaluated by IPCS prior to inclusion in their criteria document.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Male and female rats were exposed to LABS Na in drinking water daily for 9 months.
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
C10-14 LAS
sodium salt (CAS #69669-44-9)
average alkyl chain length = C11.7
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: drinking water
Vehicle:
not specified
Details on oral exposure:
LAS was provided daily in drinking water.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
nine months
Frequency of treatment:
daily in drinking water
Dose / conc.:
85 mg/kg bw/day (nominal)
Remarks:
0.07%
Dose / conc.:
145 mg/kg bw/day (nominal)
Remarks:
0.2%
Dose / conc.:
430 mg/kg bw/day (nominal)
Remarks:
0.6%
No. of animals per sex per dose:
Information as cited in IPCS document. 8-9 animals of each sex per dose group.
Control animals:
yes, concurrent no treatment
Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Body weight gain was suppressed in the male 0.6% group.
Food efficiency:
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
Hematological examination revealed no significant change in any of the experimental groups
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
a dose-related decrease in cholesterol level was seen in males. Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase were seen in males at 0.2% and a dose-related increase in the activity of gluatamate-oxalate transaminase in females. A significant decrease in renal Na,K-ATPase was seen in the group given 0.2%.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
No organ weight changes were observed.
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
The intake of LAS was 50 mg/kg bw/day in the male 0.07% group and 120 mg/kg bw/day in the female group. The values for the 0.2% group were 120 and 170 mg/kg bw/day for males and females, respectively.
Dose descriptor:
NOAEL
Effect level:
85 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: activities of glutamate-oxalate transaminase and lactate dehydrogenase and renal Na,K-ATPase
Dose descriptor:
LOAEL
Effect level:
145 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Significant decreases in the activities of glutamate-oxalate transaminase and lactate dehydrogenase in males. A significant decrease in renal Na,K-ATPase in males and females.
Critical effects observed:
not specified
Conclusions:
The test substance is established to have an NOAEL = 85 mg/kg bw/day; LOAEL = 145 mg/kg bw/day
Executive summary:

Male and female rats were exposed to Na-LAS in drinking water daily for 9 months. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the 0.2% group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively. The NOAEL represents the highest NOAEL below the lowest LOAEL.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
40 mg/kg bw/day
Study duration:
chronic
Species:
rat

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:
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:
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:
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:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity - oral

No key repeated dose toxicity study with the target substance is available. Data generated with the supporting substance LABS Na was used to cover this endpoint.

In a repeated dose toxicity study, LABS Na was dosed in male and female Sprague-Dawley rats via oral gavage at dose levels 0, 125, 250 or 500 mg/kg bw/day for 28 days. Body weight gain was suppressed, some serum biochemical measures were different from the controls, and some organ weights were either decreased (spleen, thymus, heart) or increased (liver) in either the male or female high dose groups. No mortalities or histopathological abnormalities were observed. The resultant NOAEL and LOAEL values were 125 and 250 mg/kg bw/day, respectively.

Male and female rats were exposed to LABS Na in the diet daily for 6 months. Diarrhea, suppressed growth, increased cecal weight, and degeneration of renal tubes characterized the highest dose group. Similar but less severe signs were seen in other doses with the exception of the lowest dose of 0.07%, which showed no adverse effects related to exposure to LABS Na. The resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. This represents the lowest LOAEL of any study. The substance should not be classified as STOT RE according to the CLP Regulation.

In a supporting, K2 chronic toxicity study, male and female rats were exposed to LABS Na in drinking water daily for 9 months. Body weight was suppressed in the highest dose group only. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the 0.2% group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively. The NOAEL represents the highest NOAEL below the lowest LOAEL.

Repeated dose toxicity - inhalation/dermal

A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation/dermal route of exposure.

Justification for classification or non-classification

Based on the results above, the substance is not to be classified as STOT RE according to the CLP regulation.