7-hydroxycitronellal

Endpoint summary

Description of key information

Acute toxicity:
- oral: LD50 > 6400 mg/kg bw (BASF 1972, XXI/221)
- dermal: > 2000 mg/kg bw (Moreno 1973)

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Study was performed acc. internal BASF method, which was in part equivalent to OECD Guideline 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean: 268 g (male), 183 g (female)

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2%, 20%, 30%
- Other: vehicle solution contained 2-3 drops of cremophor EL (as solubilizer)

Doses:

200, 1600, 3200, 6400 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of weighing: prior to begin and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Determination of the LD50 calculated according to Finney

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 400 mg/kg bw

Mortality:

200 mg/kg bw: 0/20 deaths
1600 mg/kg bw: 0/20 deaths
3200 mg/kg bw: 1/20 deaths; 1 male died within 48 h
6400 mg/kg bw: 0/20 deaths

Clinical signs:

other: Delayed and intermittent respiration, Dyspnea and atony

Gross pathology:

Enlarged stomach

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 800 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No reliable study performed according to regulatory guidelines was available and thus, a study for the third route of exposure was waived.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable data, report with limited documentation

Qualifier:

no guideline followed

Principles of method if other than guideline:

An acute dermal toxicity study on rabbits was performed

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

no data

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 animals used

Control animals:

other: not applicable

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality observed

Clinical signs:

other: Symptomatology: none

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

In the chosen key study for acute oral toxicity in part equivalent to OECD guideline 401, ten Sprague-Dawley rats per sex and dose were treated via gavage by doses of 200, 1600, 3200, 6400 mg/kg bw hydroxycitronellal in carboxymethyl cellulose (BASF 1972, XXI/221). One single male animal in the 3200 mg/kg dose group died, and a LD50 value of >6400 mg/kg bw was set.

In a supportive study, the LD50 was found to be >5000 mg/kg/bw when 10 rats received application of 5000 mg/kg bw (Moreno, 1973).

Acute inhalative toxicity

No valid key study is available for hydroxycitronellal. However, for the coverage of a second and human relevant route of exposure, a study on acute dermal toxicity is available. No evident acute toxicity after single oral or dermal exposure has been observed for hydroxycitronellal. In support, in an inhalation hazard test in rats (exposure to a vapour saturated atmosphere at 20°C and 40°C for 8 hours) no mortality was observed, providing further evidence for the absence of an acute inhalative toxicity potential (BASF 1972, XX/221a). Overall, no further testing in animals is considered mandatory.

Acute dermal toxicity

In the chosen key study for acute dermal toxicity in two rabbits, a LD50 of >2000 mg/kg bw has been reported (Moreno, 1973).

Justification for classification or non-classification

The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in regulation (EU) 1272/2008, and therefore, a non-classification is warranted.