Reaction mass of 3,5,5-Trimethylhexanoyl chloride and Methyl 3-methyl-2-butenoate

Endpoint summary

Description of key information

A study is available for one constituent (Conc. max. 20%) of the UVCB-Substance. For all other constituents no data are available. Therefore, according to the calculation procedure in 3.1.3.6.2.3 of the CLP-Regulation the UVCB should be classified as acute tox 4, H302.

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:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Species: Wistar Rat
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
male animals approximately 7 weeks
female animals approximately 8 weeks
- Weight at study initiation:
males: mean = 178 g, SD = 7, xmin = 171, xmax = 188, n=5
females: mean = 173 g, SD = 7, xmin = 155, xmax = 186, n=20
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
Room temperature: 22 ± 3 °C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Food: ad libitum
Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment
Water: tap water in plastic bottles, ad libitum
Animal identification: fur marking and cage numbering

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): sesame oil
- Doses applied:
2000 mg/kg bw (males)
2000 - 1600 - 1250 - 1000 mg/kg bw (females)
MAXIMUM DOSE VOLUME APPLIED:
10 ml (20% solution) = 2000 mg/kg bw

Doses:

4

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 and weighing: daily
- Necropsy of survivors performed: yes

Statistics:

no

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 481 mg/kg bw

Based on:

test mat.

Mortality:

Lethality occurred up to day 4 of the study.

Clinical signs:

The following unspecific clinical signs of intoxication were noted: irregular respiration, decreased and increased spontaneous activity, prone position, trembling, uncoordinated gait, narrowed palpebral fissure, increased fright reaction, decreased body surface temperature, clear colourless lacrimation, swollen abdomen and diarrhea.

Body weight:

Not impaired

Gross pathology:

Necropsy of the decedent animals revealed light discoloured liver and kidneys, lobular demarcation of the liver, stomach with petechial bleedings and detachment of the mucosa, red or orange discoloured lungs, urinary bladder taut with dark yellowish fluid, and blood and yellowish mucous in the small intestine.
The animals killed at the end of the observation period showed no macroscopically visible changes.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute oral toxicity testing of the test material in the Wistar rat yielded the following median lethal dose (LD50):
Female animals: 1481 mg/kg body weight
Male animals did not show a higher sensitivity to the test substance.

Executive summary:

The acute oral toxicity testing of the test material in the Wistar rat yielded the following median lethal dose (LD50):

Female animals: 1481 mg/kg body weight

Male animals did not show a higher sensitivity to the test substance.

The observation period following application was 14 days. Lethality occurred up to day 4 of the study. The following unspecific symptoms were observed: impairments of respiration, motility, consciousness and reflexes, prone position, trembling, narrowed palpebral fissure, increased fright reaction, decreased body surface temperature, clear colourless lacrimation, swollen abdomen and diarrhea. On day eight of the study the clinical symptoms had reversed in the surviving animals.

Development of body weight was not impaired.

Necropsy of the decedent allimals revealed light discoloured liver and kidneys, lobular demarcation of the liver, stomach with petechial bleedings and detachment of the mucosa, red or orange discoloured lungs, urinary bladder taut with dark yellowish fluid, and blood and yellowish mucous in the small intestine.

The animals killed at the end of the observation period showed no macroscopically visible changes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 481 mg/kg bw