Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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.