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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
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:
1987
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

Constituent 1
Reference substance name:
Cyclohexane, oxidized, aquous extract
IUPAC Name:
Cyclohexane, oxidized, aquous extract
Constituent 2
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

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.