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EC number: 272-810-4 | CAS number: 68915-38-8
Acute Toxicity: oral
Administrative data
- 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 with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited reporting
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Cyclohexane, oxidized, aquous extract
- IUPAC Name:
- Cyclohexane, oxidized, aquous extract
- Reference substance name:
- Cyclohexane, oxidized, aq. ext.
- EC Number:
- 272-810-4
- EC Name:
- Cyclohexane, oxidized, aq. ext.
- Cas Number:
- 68915-38-8
- Molecular formula:
- not available
- IUPAC Name:
- Cyclohexane, oxidized, aq. ext.
- Details on test material:
- - Name of test material (as cited in study report): Dicarbonicacid-solution, "Abstreifsäure"
- Product No.: 62252
- substance No.: 87/220
- Approx. solid content: 45%, water content: 55%
- density: 1.06g/ml (45°C)
- vapour pressure 23mbar
- 5% solution pH 2.4
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
16.7% Adipinic acid (CAS-Nr. 124-04-9)
13.2% 6-Hydroxycaproic acid (CAS-Nr.1191-25-9)
2.1% Glutaric acid (CAS-Nr. 110-94-1 )
0.8% succinic acid (CAS-Nr. 13392-69-3)
0.2% valeric acid
(CAS-Nr. 109-52-4)
0.2% butanoic acid
(CAS-Nr. 107-92-6)
0.1% propionic acid (CAS-Nr. 79-09-4)
0.3% acidic acid
(CAS-Nr. 64-19-7)
1.4% formic acid
(CAS-Nr. 64-18-6)
10% polymeric oxycaproic acid
55% water
~20ppm cobalt
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Mean weight at study initiation: male 187 g, female 183 g
- Housing: 5 per cage
- Diet: Kliba 343
- Water: tap water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Application of 10ml/kg of an aquaeous solution.
- Doses:
- 5000, 3160, 2150, 681 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations and weighing: Individual body weight was performed at the beginning of the study and at weekly interval thereafter.
- Necropsy of survivors performed: yes
- all animals which died during the study were sectioned.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- see free text
- Gross pathology:
- Deceased animals: general congestion, marked emaciation in some cases.
Gastrointestinal tract empty and inflated in some cases. Mucosa of glandular stomach reddened in some cases.
Sacrificed animals: no pathologic findings noted.
Any other information on results incl. tables
Dose (ml/kg bw) |
Mortality in males |
||||
1 day |
2 days |
7 days |
14 days |
21 days |
|
5000 |
0/5 |
0/5 |
1/5 |
1/5 |
1/5 |
3160 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
2150 |
0/5 |
0/5 |
0/5 |
0/5 |
1/5 |
681 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
Dose (ml/kg bw) |
Mortality in females |
||||
1 day |
2 days |
7 days |
14 days |
21 days |
|
5000 |
0/5 |
0/5 |
1/5 |
2/5 |
2/5 |
3160 |
0/5 |
0/5 |
0/5 |
1/5 |
1/5 |
2150 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
681 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
General signs of toxicity were:
- 5000 mg/kg bw - irregular breathing, apathy, tumbling, piloerection, bad general condition (reversible within 21 days)
- 3160 mg/kg bw - irregular breathing, apathy, tumbling, piloerection, bad general condition (reversible within 5 days)
- 2150 mg/kg bw - irregular breathing, tumbling, piloerection bad general condition (reversible within 5 days)
No symptoms were observed in the 681 mg/kg bw dose group
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- An LD50 (oral gavage, rat) of >5000 mg/kg bw was determined, suggesting that Cyclohexane, oxidized, aquous extract is practically non-toxic.
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