Registration Dossier

Administrative data

Description of key information

Based on experimental data available on two read-across substances the test item is classified as STOT RE 2 according to Regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
14 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Protocol similar to OECD 408.
System:
cardiovascular
Organ:
other: cardiovascular / hematological; urogenital: kidneys

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

No experimental data on repeated dose toxicity is available for the test item. However, experimental data for two source substances is available and a read-across approach is applied. Please refer to read-across justification document attached in IUCLID Section 13. Furthermore, only key studies of the source substances are taken into account. For further supporting information please refer to respective dossier of each source substance.

Source substance 2

CAS 68411 -30 -3

Male and female rats were exposed to LAS Na (125, 250, 500 mg/kg bw/day) orally by gavage daily for 28 days. The results showed suppressed body weight gain, differences in some serum biochemical measures when compared to the controls, and decreased (spleen, heart, thymus) or increased (liver) organ weights in the animals of the highest dose level. The resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively (Ito et al., 1978).

CAS 69669 -44-9

CAS 69669-44-9 is applied equivalent to CAS 68411-30-3 here. For read-across justification in this case please refer to REACH registration dossier of CAS 68411-30-3.

In a 6-month toxicity test male and female rats were exposed to LAS Na (CAS 69669-44-9) in the diet daily:40, 115, 340, 1030 mg/kg bw/day. 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 NOAELvalues were 115 and 40 mg/kg bw/day, respectively (Yoneyama et al., 1972).

In a 9-month toxicity study male and female rats were exposed to LAS Na (CAS 69669-44-9; 85, 145, 430 mg/kg bw/day) in drinking water daily. Body weight was suppressed in the highest dose. Significant decreases in transaminase activity and renal Na,K-ATPase was seen in the second group. The resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively (Yoneyama et al., 1976).

Source substance 3

In rats, subchronic oral treatment via the drinking water (protocol similar to OECD TG 408) caused mortality at the high dose in males (5000 ppm). Impaired body weight gains were observed at concentrations equal to or higher than 320 ppm in females and 630 ppm in males. Systemic effects consisted of anaemia, nephrotoxicity, cortical vacuolization of adrenal glands and demyelinization of brain/spinal cord without any neurofunctional finding. In males, damage of reproductive organs in the form of testicular degeneration and associated weight changes and impaired spermatology was observed. Based on anaemia observed, a LOAEL of 25/14 mg/kg bw (equal to 320/160 ppm) was achieved in males/females.

 

In the subchronic oral study in mice (protocol similar to OECD TG 408), mortality was observed in males at ≥5000 ppm and in females at ≥2500 ppm. Body weight gain was decreased in both species at concentrations of 1250 ppm (females) or 2500 ppm (males) and higher. Systemic effects consisted of hepato- and nephrotoxicity and myocardial degeneration. The most sensitive effect was necrotic liver damage at all concentrations. A LOAEL of 104/142 mg/kg bw (equal to 630/630 ppm) was noted in males/females.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data on two read-across substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The source substance DEA (CAS 111 -42 -2) is classified for specific target organ toxicity for repeated exposure cat. 2 (STOT RE 2) under Regulation (EC) No 1272/2008. Based on the composition of the test item, the constituent DEA is present in the test item at more than 10 %. Consequently, and in absence of experimental data with the test item itself, the test item is also classified for specific target organ toxicity cat 2 (STOT RE 2) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.