Registration Dossier

Administrative data

Description of key information

Read-acorss: rat, oral (gavage), single dose, 15 d, LC50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the Read-across statement attached under section 13.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This Read-Across is based on the hypothesis that the target and the source substances have similar environmental fate and (eco)toxicological properties because both substances have the same common compound octyl sulfonate while another main constituent of the target substance octyl disulfonate is considered to have similar level of toxicity as octyl sulfonate. Other non-common compounds represented by impurities are considered not to influence the read-across validity because they are either structurally identical in the target and in the source substances or, if different, do not contribute to the toxicity effects because they are also anionic sulfonates with the same functional groups and their content is very low.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to the Read-across statement attached under section 13.

3. ANALOGUE APPROACH JUSTIFICATION
The acute toxicity potential of the anionic surfactants (ANS category) is reported to be low (SIDS, 2007). The source substance was practically non-toxic in the acute toxicity study with rats (LD50 >5000 mg/kg bw).
Since the main constituents and most of the impurities of the target substance are also anionic surfactants with the same functional groups and the same length of hydrophobic carbon octyl chain, the same mode of toxicological action is expected for the target and the source substances. The constituents of the target substance do not possess functional groups associated with other mode of actions or toxicity effects. Toxicokinetic behavior of the constituents of the target substance is expected to be essentially the same as that of the source substance. The second main constituent octyl disulfonate is a more hydrophilic chemical than octyl sulfonate, the common compound, so that its absorption through the GI tract may be even lower than the absorption of octyl sulfonate. If absorbed, octyl disulfonate is expected to be more rapidly excreted via the urine because of higher hydrophilicity of two sulfonate groups. The impurities are also structurally similar to the main constituents with octyl rest and sulfonate groups at different positions. The minor amounts of other impurities (hexadecyl sulfonate, octyl sulfinosulfonate, benzoic acid and tert-butyl alcohol) are not expected to impact toxicity profile of the target substance, if it was tested in an acute oral study, because they do not contain functional groups with other mode of action and their amounts are very low. Therefore, it is predicted that the target substance would possess the same toxicity potential by acute oral exposure as the source substance.

4. DATA MATRIX
Please refer to the Read-across statement attached under section 13.
Reason / purpose:
read-across source
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
95% CL:
> 0 - < 27
Remarks on result:
other: only one dose tested
Remarks:
predicted result from the source substance
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: only one dose tested
Remarks:
predicted result from the source substance
Mortality:
0 %; 0 of 10 rats died within the 15 day observation period
Clinical signs:
No clinical signs observed. All animals appeared normal throughout the study.
Body weight:
males: initial: 255.4 ± 9.3; day 15: 345.8 ±20.8
females: initial: 219.4 ±13.0; day 15: 260.0 ±12.9
Gross pathology:
no pathology performed
Other findings:
no details given
Interpretation of results:
GHS criteria not met
Conclusions:
In the acute toxicity study in rats with the source substance sodium octane-1-sulfonate no mortality was observed at 5 g/kg bw (LD50 > 5000 mg/kg bw).The same result is predicted for the target substance.
Executive summary:

The source substance Sodium octane-1-sulphonate monohydrate (EC 226 -195 -4; CAS 5324-84-5) was evaluated for acute oral toxicity in five male and five female Sprague-Dawley rats. The test article was administered by gavage to each of ten rats at a level of 5.0 g/kg body weight. All animals survived the 15 day post-administration observation period. No clinical signs of toxicity were observed during the observation period. Therefore the LD50 value is > 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Sodium octane-1-sulphonate monohydrate (EC: 226-195-4; CAS: 5324-84-5) was evaluated for acute oral toxicity in five male and five female Sprague-Dawley rats similar to OECD Guideline 401. The test article was administered by gavage to each of ten rats at a level of 5.0 g/kg body weight. All animals survived the 15 day post-administration observation period. No clinical signs of toxicity were observed during the observation period. Therefore the LD50 value is > 5000 mg/kg bw (Reagan 1985).

Justification for classification or non-classification

Based on the available data on the source substance, the registered substance does not need to be classified according to Regulation (EC) No 1272/2008.