Cyclohexane-1,2,4-triyltris(ethylene)

Endpoint summary

Description of key information

In an acute oral dose study in male and female rats with TVCH, 2 out of 10 or 3 out of 10 animals died following administration of 3980 or 5010 mg/kg, respectively.

The following clincial signs were observed beginning 30 to 60 minutes after administration: piloerection, hunched posture, diarrhea, diuresis, unsteady gait, increased drinking water consumption, ataxia, tremor, sedation, clonic convulsions, lateral and prone position. After 7 days all observations have been subsided.

Acute toxicity studies by the inhalation and dermal routes of exposure have been waived because of exposure considerations and available information.

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

Study period:

28.02. - 18.03.1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Bor: WISW (SPF TNO)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 4799 Borehen
- Sex: male and female
- Weight at study initiation: males 178.8 g; females 136.8 g (mean)
- Fasting period before study: yes
- Housing: 1 - 5 animals in Makrolon cages Type III
- Diet (e.g. ad libitum): RlO Alleindiät für Ratten, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4 to 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 1°C
- Humidity (%): 60 % +/- 5 %
- Air changes (per hr): 15fold
- Photoperiod (hrs dark / hrs light): 12h/12h

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test substacne was applied unchanged in a volume of 4.66 and 5.86 ml/kg, resepctively.

Doses:

3980 and 5010 mg/kg

No. of animals per sex per dose:

5 male / 5 female

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

2 out of 5 females and no male died during 7 days after administration of 3980 mg/kg, whereas 2 out of 5 females and 1 out of 5 males died during the first 2 days after administration of 5010 mg/kg

Clinical signs:

other: The following clincial signs were observed beginning 30 to 60 minutes after administration: piloerection, hunched posture, diarrhea, diuresis, unsteady gait, increased drinking water consumption, ataxia, tremor, sedation, clonic convulsions, lateral and p

Gross pathology:

Hyperaemia of the mucosa of stomach and intestines was observed in 4 or 3 animals, respectively. In two animals the stomach was adhered to liver, spleen and pancreas. One animal had a congesetd liver and in one animal the mucosa of the small intestine was pale.

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral dose study in male and female rats with TVCH, 2 out of 10 or 3 out of 10 animals died following administration of 3980 or 5010 mg/kg, respectively. Thus, the LD50 is >5000 mg/kg, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Furthermore, in the same study transient narcotic effects were observed, thus, classification for specific target organ toxicity following single exposure, category 3 (STOT SE 3) is warranted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

The LD50 in an acute study by the oral route with TVCH was determined to be >5000 mg/kg. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification. In the same study transient narcotic effects were observed, thus, classification for specific target organ toxicity following single exposure, category 3 (STOT SE 3) is warranted.