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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962
Report date:
1962

Materials and methods

Principles of method if other than guideline:
BASF-Test: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Cyclohexane, oxidized, non-acidic by-products, distn. residues
EC Number:
271-816-4
EC Name:
Cyclohexane, oxidized, non-acidic by-products, distn. residues
Cas Number:
68609-04-1
IUPAC Name:
(1s,4s)-cyclohexane-1,4-diol (cyclohexyloxy)cyclohexane 2-butylcyclohexan-1-one 8-oxatricyclo[7.4.0.0^{2,7}]trideca-1(9),2(7)-diene cyclohexane cyclohexane-1,3-diol cyclohexanol phenol hydrate
Details on test material:
- Name of test material (as cited in study report): Liquid Anon-destillation residue
- condensation products of cyclohexanol and cyclohexanon of unknown chemical structure. Ash-content approx. 2% (determined as sulfate-ash).

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean weight at study initiation:
2000 mg/kg bw: male 20-26 g, female 20-23 g
1600 mg/kg bw: male 26-35 g, female 16-23 g
1250 mg/kg bw: male 26-32 g, female 22-26 g
1000 mg/kg bw: male 23-30 g, female 18-26 g
800 mg/kg bw: male 27-33 g, female 23-27 g
640 mg/kg bw: male 22-30 g, female 21-25 g
500 mg/kg bw: male 22-33 g, female 16-32 g
400 mg/kg bw: male 22-27 g, female 21-23 g
200 mg/kg bw: female 17-23 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: traganth
Details on exposure:
VEHICLE
- Concentration in vehicle (%): 2, 4, 8 and 20
Doses:
2000, 1600, 1250, 1000, 800, 640, 500, 400 and 200 ml/kg bw (corresponding to 2103, 1682, 1314, 1052, 841, 673, 526, 421 and 210 mg/kg bw) Calculation based on the density of the test substance (1.0515 g/cm3 at 20 °C)
No. of animals per sex per dose:
5 for 400-2000 ml/kg bw dose groups,
5 (only females) for 200 ml/kg bw dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: mortality and clinical signs of toxicity were observed several times on the application day and thereafter once each working day, body weights were only recorded at the beginning of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 1 682 mg/kg bw
Mortality:
see free text
Clinical signs:
agitation, trembling, apathy later atony, lateral position, narcosis state
Gross pathology:
Deceased animals: skicky organs in the abdominal cavity.
Sacrificed animals: substance rests on the serosa of abdominal organs

Any other information on results incl. tables

Dose (ml/kg bw)

Mortality in

24 h

48 h

7 days

10 days

2000

5/10

8/10

9/10

10/10

1600

1/10

3/10

4/10

4/10

1250

0/10

0/10

3/10

3/10

1000

0/10

0/10

0/10

0/10

800

0/10

0/10

1/10

1/10

640

0/10

0/10

0/10

0/10

500

0/10

0/10

0/10

0/10

400

0/10

0/10

0/10

0/10

200

0/5

0/5

0/5

0/5

LD50 = 1600 ml/kg bw (corresponding to 1682 mg/kg bw)

Applicant's summary and conclusion