Registration Dossier

Administrative data

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

Additional information

Justification for classification or non-classification

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