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EC number: 254-159-8 | CAS number: 38861-78-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Feb 1987
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- EC Number:
- 254-159-8
- EC Name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- Cas Number:
- 38861-78-8
- Molecular formula:
- C12H16O
- IUPAC Name:
- 1-[4-(2-methylpropyl)phenyl]ethan-1-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: SN 9707
- Expiration date of the batch: not available
- Purity: > 95%
- Appearance: Pale yellow liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability, homogeneity and purity were the responsibility of the Sponsor.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd/Ola:Sprague-Dawley (CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: Approximately four to seven weeks
- Weight at study initiation: 106 g - 132 g
- Fasting period before study: Overnight prior to and approximately four hours after dosing
- Housing: In groups of five
- Diet: Standard laboratory rodent diet (Biosure LAD 1), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: Seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 45 (mean)
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12, 0700 - 1900 light phase
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.06 ml/kg using a syringe and plastic catheter
- Doses:
- 2,000 mg/kg bw
- 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: Check for any mortalities at least twice daily. Bodyweight of each rat was recorded on Days 1 (prior to dosing), 8, and 15. Individual weekly bodyweight chnages were calculated.
- Necropsy of survivors performed: yes, animals were killed on Day 15 by cervical dislocation
- Other examinations performed: clinical signs (animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 - a period of five hours. On subsequent days, animals were observed once in the morning and again at the end of the experimental day), macroscopic pathology (opening the abdominal and thoracic cavities, appearance of all tissues was recorded)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: Pilo-erection and increased salivation were observed in all rats within five minutes of dosing. Pilo-erection persisted and was accompanied at later intervals on Day 1 by abdominal body carriage (hunched posture) and abdominal gait (waddling). Recovery of
- Gross pathology:
- No macroscopic abnormalities were observed.
Any other information on results incl. tables
Table 1: Clinical signs of reaction to treatment observed in rats
Signs |
No. of rats in group of 5 showing signs |
|
Dose (g/kg) |
||
2.0 |
||
males |
females |
|
Pilo-erection |
5 |
5 |
Abnormal body carriage (hunched posture) |
5 |
5 |
Abnormal gait (waddling) |
5 |
5 |
Increased salivation |
5 |
5 |
Table 2: Individual bodyweights
Sex |
Dose (g/kg) |
Animal number and ear mark |
Bodyweight (g) at |
||
|
|
|
Day 1 |
Day 8 |
Day 15 |
Males |
2.0 |
1 RP 2 LP 3 RPLP 4 RIRO 5 LILO |
131 130 125 132 128 |
184 192 197 200 183 |
234 236 249 254 226 |
Females |
2.0 |
6 RP 7 LP 8 RPLP 9 RIRO 10 LILO |
125 116 114 106 122 |
163 158 156 141 167 |
174 196 176 158 192 |
Table 3: Individual bodyweight changes
Sex |
Dose (g/kg) |
Animal number and ear mark |
Bodyweight (g) at |
|
|
|
|
Week 1 |
Week 2 |
Males |
2.0 |
1 RP 2 LP 3 RPLP 4 RIRO 5 LILO |
53 62 72 68 55 |
50 44 52 54 43 |
Females |
2.0 |
6 RP 7 LP 8 RPLP 9 RIRO 10 LILO |
38 42 42 35 45 |
11 38 20 17 25 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal oral dose to rats of the test substance was found to be greater than 2,000 mg/kg bodyweight. The test substance does not require labelling with the risk phrases R22 "Harmful if swallowed", in accordance with Council Directive 79/831/EEC Annex VI, Part II(D) as described in Commission Directive 91/325/EEC.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test substance to the rat. The method followed was that described in:
- EEC Methods for the determination of toxicity, Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B. 1. Acute toxicity (oral).
- EPA Health Effects Testing Guidelines, Subpart B - General Toxicity Testing 5798.1 175 Acute oral toxicity, September 27, 1985 (described in Federal Register Vol. 50, No. 188) and subsequent revisions. Subpart B provides detailed information relating to data requirements of 40 CFR Part 158 and supports the Toxic Substances Control Act (TSCA).
- OECD Guideline for Testing of Chemicals No. 401 "Acute Oral Toxicity". Adopted: 24 February 1987.
A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, as supplied, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths. Clinical signs of reaction to treatment included pilo-erection, abnormal body carriage, abnormal gait and increased salivation; recovery was complete by Day 2. All rats achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. No target organs were identified on the basis of clinical observations and macroscopic observations at necroscopy .
The acute lethal oral dose to rats was found to be greater than 2.0 g/kg bodyweight.
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