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Endpoint summary

Description of key information

Acute Toxicity: Oral 211376:

According to the TG OECD 423 and the EU method Part B.1 tris, the acute oral toxicity test carried out under GLP conditions revealed that the LD₅₀ for male and female Wistar rats was >2000 mg/kg bodyweight.

Acute Toxicity: Oral P-6029:

Under the conditions of this study, the acute oral approximate lethal dosage (LD₅₀) was more than 2g/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 October - 27 October, 1997

Reliability:

2 (reliable with restrictions)

GLP compliance:

not specified

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: about 7-weeks-old
- Weight at study initiation: 266-287g
- Fasting period before study: on t h e day of dosing test material
- Housing: polycarbonate cages with stainless steel grid tops
- Diet: complete pelleted rodent diet
- Water: Tap water was available ad libitum
- Acclimation period: 7 days prior to the test

ENVIRONMENTAL CONDITIONS
- Temperature: 25 ± 3 'C
- Humidity: 50 ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light / dark cycle per day

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

single dose

Doses:

2g/kg bodyweight

No. of animals per sex per dose:

five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0 , 7 and 14
- Necropsy of survivors performed: yes
- Body weight: days 0, 7 and 14 after treatment

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Clinical observations showed no death in all animals during the study.

Clinical signs:

other: Clinical observations showed no abnormal signs in all animals during the study.

Other findings:

See attachment for results.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral approximate lethal dosage (LD50) was more than 2g/kg bodyweight.
Therefore, the test substance can be classified as category of "non-toxic" or "slightly toxic" according to Hodge and Sterner ( Ind . Hyg. Quart . , l0, p. 93-96 (1949)).

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 21 August, 1997 to 04 November, 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

- Appearance: Colorless liquid
- Purity: 91.56%
- Lot number: 970708

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Number of animals:6
-Conditions
Air-conditioned room with approximately 15 air changes per hour and the environment controlled
with optimal conditions considered as being a temperature of 21 °C and a relative humidity of 50%.
Fluctuations from these optimal conditions were noted, but were considered not to have affected
study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
-Accommodation
Group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified
sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands). Certificates
of analysis were examined and then retained in the NOTOX archives. Acclimatisation period was at
least 5 days before start of treatment under laboratory conditions.

Route of administration:

oral: gavage

Vehicle:

other: None, administered undiluted

Details on oral exposure:

-Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the
test substance.

Doses:

Single dosage, on day1
Dose level (volume) : 2000 mg/kg (2.33 mL/kg) body weight
Dose volume calculated as follows: dose level (g/kg):density (0.86 g/mL)

No. of animals per sex per dose:

Each dose group consisted of 3 animals of one sex. Famales were nulliparous and non-pregnant.

Control animals:

no

Details on study design:

-The test substance was tested using a stepwise procedure with a starting dose level of 2000 mg/kg b
ody weight.
-The absence or presence of mortality of animals dosed at one step determined the next step, ac
cording to the test procedure defined in the guidelines and NOTOX Standard Operating Procedure
DIE H/123.
-The onset, duration and severity of the toxic sign were taken into account for determination of the
time interval between the dose groups.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture was noted in all females between days 1 and 3, piloerection was noted in two females on day 1 and uncoordinated movements and abnormal gait were observed in one female on day 1 and days 2 and 3 respectively. No clinical signs were observed

Gross pathology:

Macroscopic Findings
-No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of DIHYDROFARNESOL in Wistar rats was established as exceeding 2000 mg/
kg body weight. Based on these results and according to the EC criteria for classification and lab
elling requirements for dangerous substances and preparations (Guidelines in Commision Directive
93/21/EEC), DIHYDROFARNESOL does not have to be cllassified and has no obligatory labelling
requirement for oral toxicity.

Executive summary:

Assessment of acute oral toxicity with DIHYDROFARNESOL in the rat (Acute Toxic Class Method)

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC,

Part B.1 tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No. 423, "Acute Oral Toxicity-

Acute Toxic Class Method".

Initially, DIHYDROFARNESOL was administered by oral gavage to three male Wister rats at 2000 mg/

kg body weight. In a stepwise procedure an additional group of females was dosed at 2000 mg/kg

body weight. All animals were subjected to daily observations and weekly determination of body weight.

Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred.

Hunched posture was noted in all females betweens day 1 and 3, piloerection was noted in two females

on day 1 and uncoordinated movements and abnormal gait were observed in one female on day 1 and

days 2 and 3 respectively.

No clinical signs were observed in the males.

Body weight gain shown by the animals over the study preiod was considered to be normal.

No abnormalities were found in the animals at macroscopic post mortem examination.

The oral LD50 value of DIHYDROFARNESOL in Wistar rats was established as exceeding 2000 mg/

kg body weight.

Based on these results and according to the EC criteria for classification and labelling requirements

for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC),

DIHYDROFARNESOL does not have to be classified and has no obligatory labelling requirement for

oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Reliability 1