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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Three repeated dose studies via oral exposure are reported. The NOAEL value of 85 mg/kg bw/day represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
85 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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

Three repeated dose toxicity studies are available. In the key study, groups of 15 male and 15 female rats were fed doses of 0, 50, or 250 mg/kg/day of ABS or LAS in the diet. Exposure lasted 12 weeks. Animals were observed daily for clinical signs. Body weights were taken weekly. Blood and urine analyses were done at week 6 and 12 of exposure. At the end of the exposure period, all animals were sacrificed and gross pathology and histopathology exams performed. Rats of both sexes in the high dose ABS groups showed increased liver weights. Female rats in the high dose LAS group also showed increased liver weights. Males in the high dose LAS group showed increased cecal weights. Based on these endpoints, the 12-week NOAEL for both ABS and LAS was 50 mg/kg/day. The 12-week LOAEL for both ABS and LAS was 250 mg/kg/day. In a second study, 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. In the third study, 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.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

Three repeated dose studies via oral exposure are reported. The NOAEL value of 85 mg/kg bw/day represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment.

Justification for classification or non-classification

Based on the results of the oral repeated dose studies, the appropriate LOAEL and NOAEL values for use in the assessment are 145 and 85 mg/kg bw/day, respectively. These values do not meet the criteria for classification under the DSD or CLP and therefore the substance is not classified.