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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Effect level:
>= 85 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical biochemistry
Remarks on result:
other: NOAEL refers to 0.07% dose group
Key result
Critical effects observed:
yes
Lowest effective dose / conc.:
145 mg/kg bw/day (actual dose received)
System:
hepatobiliary
Organ:
kidney
liver
other: body weight gain
Treatment related:
yes
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
85 mg/kg bw/day
Study duration:
subchronic
Species:
rat
System:
hepatobiliary
Organ:
kidney
liver
other: body weight gain

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the OECD SIDS document (2005) the results of oral repeated dose toxicity studies are summarised as follows:

“Many studies have investigated the effects of repeated doses of LAS via the oral exposure route, mainly in the feed but also by gavage and through the drinking water. In a key study, groups of 8 or 9 rats of each sex were given LAS in drinking water at equivalent doses of 85, 145, and 430 mg/kg bw/day for 9 months (Yoneyama et al. 1976). Body weight gain was suppressed in the male 430 mg/kg bw/day group. Hematological examination revealed no significant change in any of the experimental groups, but 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 the middle dose and a dose-related increase in the activity of glutamate-oxalate transaminase in females. A significant decrease in renal Na,K-ATPase was seen in the middle-dose group. No organ weight changes were observed. The NOAEL is 85 mg/kg bw/day.

Other studies show similar responses, with commonly reported effects at higher doses including diarrhea, suppression of body weight gain, increases in relative weight of the liver, changes in other organ weights, differences in enzymatic and serum-biochemical parameters (e.g., ATPase, LDH, G6Pase), and mild degeneration and desquamation of the tubular epithelium in the kidneys. Occasionally, other effects have been observed, including marked degeneration of renal tubes, proteinaceous degeneration in the liver, and effects on subcellular components (Yoneyama et al. 1972; Gupta et al. 1986; Mathur et al. 1986; Watari et al., 1977).”

 

The NOAEL derived from the key study (9 months dosing via drinking water) amounts to 85 mg/kg body weight/day. This value is just below the threshold value of 100 mg/kg/day indicated for classification as STOT RE 2. However, this threshold value applies to 3 months repeated dosing. In addition, none of the different linear alkylbenzene sulfonate compounds covered in the OECD SIDS document is classified for specific target organ toxicity. Accordingly, non-classification of calcium salt of linear alkyl benzenesulfonic acid (the target substance to be registered) is considered justified.

Justification for classification or non-classification

Based on the available toxicological information non-classification of calcium salt of linear alkyl benzenesulfonic acid (the target substance to be registered) is considered justified