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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Appearance: Colorless liquid
- Purity: 91.56%
- Lot number: 970708

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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.

Administration / exposure

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.

Results and discussion

Effect levels
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:
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 in the males.
Body weight:
The body weight gain shown by athe animals over the study period was considered to be similar to
that expected of normal untreated animals of the same age and strain.
Gross pathology:
Macroscopic Findings
-No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

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.