Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
To address toxicological endpoints as part of the REACH registration of Cyclamen Aldehyde Extra (Target substance) It is proposed to read across to Florhydral (Source substance) The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD QSAR toolbox . From the profiling in this table , it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Code number : R0 82-4130/O00.
Chemical designation : 3-(3-isopropylphenyl) butanal.
origin : Givaudan Clifton.
Lot number : 8906-87.
Data sheet : Dr. P. Tullen, 10.3.1988, Givaudan SA, CH—12l4 Vernier.
Physical condition : Liquid.
Degree of purity : 95.4 %.
Preparation of test article : The test article was suspended in Standard Suspending Vehicle (SSV}*.

Test animals

Species:
rat
Strain:
other: RORO (SPF) (Fü-albino SPF rat)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Rat, outbred stock, IBn: RORO (SPF), also known as Fü-albino SPF rat.
- Age at study initiation:5-6 weeks
- Weight at study initiation: Males: 107.3-130.6g Females: 111.7-118.7
- Fasting period before study: no data
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Air changes (per hr): no data (air conditioned room)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Standard Suspending Vehicle (SSV)*
Details on oral exposure:
VEHICLE
*Standard Suspending Vehicle: 1000 ml SSV contains: 5 g sodium carboxy methyl cellulose, 4 ml Tween 80, 5 ml benzylalcohol, 9 g sodium—chloride, made up to 1000 ml with distilled water.
- Concentration in vehicle: 2000 mg/kg @ 10 ml/kg ∴ 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male / 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: days 0 (before treatment), 4, 7, 12, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Mortality — Recorded continuously.
Symptoms — A detailed inspection with regard to behaviour vivacity, signs of injury, signs of sickness and abnormality was performed on the treatment day (repeatedly) and during the treatment—free observation period (daily). All symptoms deviating from normal were recorded for each individual rat.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occured
Clinical signs:
no incompatibility reactions appeared
Body weight:
the body weight development of males and females too a normal course known for the species and age of the test group.
Gross pathology:
No autopsy findings were seen.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single—dose oral toxicity study with the fragrance ingredient florhydral was performed on rats. At a dose level of 2000 mg/kg body weight, no deaths and no adverse effects occurred. The acute oral toxicity of the test substance in rats is greater than 2000 mq/kg.