tert-dodecanethiol

Endpoint summary

Description of key information

Oral route

The potential acute toxicity of tert-dodecanethiol, following a single oral administration (gavage) to rats was evaluated in a study conducted in compliance with OECD Guideline No. 423 (Tarcai, 2017). Tert-dodecanethiol in corn oil was administered once by oral route (gavage) at the dose level of 2000 mg/kg bw to two groups of three fasted female Wistar rats under a dosage-volume of 10 mL/kg. After the first assay with 3 females, as no mortality was observed, the results were confirmed in other 3 females. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on days 0 (prior to administration), 7 and 14. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No unscheduled deaths occurred during the study. Hunched back up to Day 2, incoordination (score 1) up to Day 1 in 6/6 animals and red discharge around the nose in 3/6 animals on Day 1 were observed. The animals were symptom-free from Day 3. When compared to historical control data, no change in body weight gain was noted. No macroscopic finding was observed. The oral LD0 of tert-dodecanethiol was higher than 2000 mg/kg in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17th Dec. 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 150-300 g
- Fasting period before study: yes
- Housing: group caging (3 animals/cage)
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice–breeding and maintenance"
- Water (e.g. ad libitum): tap water from the municipal supply
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals will be observed individually after dosing at least once during the first 30 minutes, then 1, 2, 3, 4 and 6 hours after the treatment and once each day for 14 consecutive days thereafter. The body weights will be recorded on Days -1 (prior to removal of food), 0 (prior to administration), 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

None

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Hunched back up to Day 2, incoordination (score 1) up to Day 1 in 6/6 animals and red discharge around the nose in 3/6 animals on Day 1 were observed. The animals were symptom-free from Day 3.

Body weight:

No effect.

Gross pathology:

No effect.

Interpretation of results:

GHS criteria not met

Executive summary:

The potential acute toxicity of tert-dodecane thiol, following a single oral administration (gavage) to rats was evaluated in a study conducted in compliance with OECD Guideline No. 423. Tert-dodecane thiol in corn oil was administered once by oral route (gavage) at the dose level of 2000 mg/kg bw to two groups of three fasted female Wistar rats under a dosage-volume of 10 mL/kg. After the first assay with 3 females, as no mortality was observed, the results were confirmed in other 3 females. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on days 0 (prior to administration), 7 and 14. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No unscheduled deaths occurred during the study. Hunched back up to Day 2, incoordination (score 1) up to Day 1 in 6/6 animals and red discharge around the nose in 3/6 animals on Day 1 were observed. The animals were symptom-free from Day 3. When compared to historical control data, no change in body weight gain was noted. No macroscopic finding was observed. The oral LD0 of tert-dodecane thiol was higher than 2000 mg/kg in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 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

Justification for classification or non-classification

According to the available data and CLP criteria, no classification is warranted for the acute toxicity.

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