Menthane, monohydroperoxy derivative

Endpoint summary

Description of key information

The LD50 value of the test substance tested in rats  is > 2000 mg/kg bw. This is confirmed by tests with the structural analogues cumene hydroperoxide (Dow 1975) and diisopropyl benzene hydroperoxide (Hüls 1984). No additional acute toxicity studies were performed with the test substance due to its corrosive properties.  A dermal toxicity study in rabbits  with the structural analogue cumene hydroperoxide  is available, but is considered unsuitable for evaluation in view of the low quality.

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:

12/04 to 11/05 1994

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 (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Hsd/Win:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33167 Borchen
- Age at study initiation: young adults
- Weight at study initiation: Males 148-184 g; Females 131-144
- Fasting period before study: 16 hours before application until 3 hours after application
- Housing: 5 animals/macrolon III cage
- Diet: Ssniff standard laboratory rat feed ad libitum
- Water: ad libitum
- Acclimation period: > 5 days

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

IN-LIFE DATES: From: 12-04-1994 To: 11-05-1994

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.2 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs at 0.5, 1, 2 ,3, 4, 5, 6 hours post dosing and daily thereafter for 14 days
body weight on day 0, 7 and 14
- Necropsy of survivors performed: yes, macroscopic examination

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Males: abnormal gait, hunched posture ,flat body posture, ventro-lateral recumbency, piloerection, ataxia, diarrhea hypothermia in all males until day 4 abnormal gait, hunched posture and piloerection persisting in one male until day 14 Females: abnorma

Gross pathology:

adhesions of abdominal organs to the peritoneum and cartilage like thickening of peritoneum
gastrointestrinal tract adhesions

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Rats received the test substance at 2000 mg/kg bw by oral gavage. No mortality was observed. The oral LD50 is > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

guideline study under GLP

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Quality of whole database:

only 2-4 animals tested per dose. According to the poor study quality, the study does not allow conclusions for the test substance.

Additional information

Data requirements on all acute toxicity endpoints are fulfilled. Due to the corrosiveness of the test substance no additional studies need to be performed (Column 2 of Annex VIII).

Justification for selection of acute toxicity – oral endpoint
guideline study under GLP

Justification for selection of acute toxicity – dermal endpoint
Based on a study with the structural analogue cumene hydroperoxide. As the test substance is corrosive, no additional testing needs to be performed according to column 2 of Annex VIII

Justification for classification or non-classification

The test substance does not need to be classified for acute toxicity. No classification is necessary. The dermal study with the analogue is considered not adequate. As the substance is corrosive no additional animal data will be generated (waiver based on column 2 of Annex VIII).