Phenol, 2,4-bis[(dodecylthio)methyl]-6-methyl-

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Further description: F3-hybrid of RII 1/Tif x RII 2/Tif
- Source: Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 173-195 (within ± 20% of mean value)
- Fasting period before study: overnight prior to dosing
- Housing: 5 per sex in Macrolon cage type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: ad libitum; Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),
- Water: ad libitum
- Acclimation period: 6 days
- Rationale for choice: The rat has been selected for this test as being a standard species for the determination of an acute oral LD50

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: mortality; daily; a.m. and p.m. on working days, a.m. on weekend days, clinical signs of toxicity; daily
- Frequency of weighing: on days 1, 7, and 14
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: No deaths occurred

Mortality:

No deaths occurred

Clinical signs:

other: Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, beginning as early as 1 hour post dosing and lasting up to 10 day. The animals were fully recovered within 11 days.

Gross pathology:

No deviations from normal morphology were found.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Justification for selection of acute toxicity – oral endpoint
The rat acute oral LD50 of the test substance is considered to be greater than 5000 mg/kg body weight, based on the results of a study on a close analogue (OECD 401).

Justification for classification or non-classification

Not classified for acute oral toxicity, according to the criteria of CLP regulation EC No.1272/2008.