3-Pentanone, 1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-, reaction products with 2-propyn-1-ol

Endpoint summary

Description of key information

Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw.

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:

The study was conducted in 1977.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and there is no documentation on experimental conditions. However, this did not influence the reliability of the results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males/dose

Control animals:

no

Details on study design:

- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Clinical signs included diarrhea.

Gross pathology:

Necropsy revealed dark liver and dark kidneys.

Interpretation of results:

other: Not classified: criteria not met.

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed an LD50 greater than 5000 mg/kg bw.

Executive summary:

Acute oral toxicity of Grisalva was studied in rats, performed according to the protocol similar to OECD Guideline 401. Ten male Wistar rats received a single dose of 5000 mg/kg bw by gavage. Animals were observed for 14 days and necropsied. There were no deaths. The only clinical sign was diarrhea. Necropsy revealed dark liver and dark kidneys. Based on the results of the study, LD50 was > 5000 mg/kg bw.Based on the results of this study, the test substance is orally not harmful and does not need to be classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity of Grisalva was studied in rats, performed according to the protocol similar to OECD Guideline 401. Ten male Wistar rats received a single dose of 5000 mg/kg bw by gavage. Animals were observed for 14 days and necropsied. There were no deaths. The only clinical sign was diarrhea. Necropsy revealed dark liver and dark kidneys. Based on the results of the study, LD50 was > 5000 mg/kg bw. Based on the results of this study, the test substance is orally not harmful and does not need to be classified.

Justification for classification or non-classification

Based on oral LD50 > 5000 mg/kg bw in rats, the substance does not have to be classified as acute orally toxic by the oral route in accordance with EU CLP regulation (1272/2008) and its amendments.