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Administrative data

Description of key information

Acute toxicity oral: LD50 = 200 mg /kg bw.
Acute toxicity dermal: LD50: 200 - 316 mg/kg bw
Acute toxicity ihalalation: LC50 > 1.4 mg/L

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No histopatological evaluation
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Single oral application by gavage, undiluted TS., 5 doses, observation time 14d, determination of signs of intoxication, stat.method:probit analysis.
GLP compliance:
not specified
Test type:
other:
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
male
Dose descriptor:
LD50
Effect level:
200 mg/kg bw
Based on:
not specified
Mortality:
Dose: number of dead rats (time of death)// number of rats with symptoms
0.16 ml/kg bw: 0/10 (-) // 10/10
0.18 ml/kg bw: 1/10 (3h) // 10/10
0.20 ml/kg bw: 5/10 (3h) // 10/10
0.25 ml/kg bw: 7/10 (3h) // 10/10
0.30 ml/kg bw: 10/10 (2h-2d) // 10/10
Clinical signs:
tonical cramps, sedation, poor general condition
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 200 mg/kg bw.
Executive summary:

The oral LD50 in the rats was 200 mg/kg bw. Signs of intoxication were tonical cramps, sedation, poor general condition

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
200 mg/kg bw
Quality of whole database:
reliability level of 2

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on putiry of TS, no data on GLP.
Qualifier:
no guideline available
Principles of method if other than guideline:
6 male Sprague-Dawley Albino rats were exposed to dicyclohexylamine vapor; concentration: 1.4 mg/l
Chamber temperature: 27 degree C
Chamber humidity: 80 %
Chamber volume: 35 l
Air flow rate: 4.0 l/min
Vaporized sample: 2.1 g
Record of signs of intoxication, gross autopsy
GLP compliance:
not specified
Test type:
other:
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
dicyclohexylamine vapor;
concentration: 1.4 mg/l
Chamber temperature: 27 degree C
Chamber humidity: 80 %
Chamber volume: 35 l
Air flow rate: 4.0 l/min
Vaporized sample: 2.1 g
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
concentration: 1.4 mg/l
No. of animals per sex per dose:
6
Control animals:
not specified
Sex:
male
Dose descriptor:
LC50
Effect level:
> 1.4 mg/L air
Based on:
not specified
Exp. duration:
6 h
Mortality:
Mortality: 0/6
Clinical signs:
slight lethargy during exposure; no toxic signs following exposure
Body weight:
no data
Gross pathology:
none reported
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50> 1.4 mg/l
Executive summary:

LC50> 1.4 mg/l, no deaths occured, no gross pathology recorded, slight lethargy was reported during exposure; with no toxic signs following exposure

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
reliability level of 2

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No data on purity, different number of rabbits/group.
Qualifier:
no guideline available
Guideline:
other:
Principles of method if other than guideline:
4 dose groups: 126 mg/kg (1 male), 200 mg/kg (2 males and 3 females), 316 mg/kg (1 female), 501 mg/kg (1 male); 24-h exposure; TS undiluted; post application observation period: 14 days, record of signs of intox., gross autopsy
GLP compliance:
not specified
Test type:
other:
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
4 dose groups: 126 mg/kg (1 male), 200 mg/kg (2 males and 3 females), 316 mg/kg (1 female), 501 mg/kg (1 male); 24-h exposure;
Duration of exposure:
24h
Doses:
126, 200, 316, 501
No. of animals per sex per dose:
4 dose groups: 126 mg/kg (1 male), 200 mg/kg (2 males and 3 females), 316 mg/kg (1 female), 501 mg/kg (1 male); 24-h exposure;
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
200 - 316 mg/kg bw
Mortality:
time of mortality: within 16 hours
Clinical signs:
reduced appetite and activity (2-3 days in survivors), increasing weakness, collapse, and death
Gross pathology:
dead animals 0 hemorrhagic areas of the lungs, liver discoloration, enlarged gall bladder, and gastrointestinal inflammation
survivors: viscera appeared normal

dosage    initial weight (kg)      Mortality
mg/kg
       male  female         male  female

126
        2.0             -             0/1     -
200
        2.0            2.4          1/2    0/3
316
         -             2.1             -     1/1
501
        2.1             -             1/1     -

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 200 - 316 mg/kg bw.
Executive summary:

LD50: 200-316 mg/kg bw (male/female), reduced apetite and activity repoerted for survivors.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
200 mg/kg bw
Quality of whole database:
reliability level of 2

Additional information

The key study for acute oral toxicity reported LD50 of 200 mg/kg bw. Signs of intoxication were tonical cramps, sedation and poor general condition.

The LD50following dermal application to rabbits ranged between 200 and 316 mg/kg bw. The LC50 for acute inhalation toxicity was not established; there were no toxic signs following exposure (LC50 > 1.4 mg/L).

Justification for selection of acute toxicity – oral endpoint
The study with lower LD50 was chosen.

Justification for selection of acute toxicity – inhalation endpoint
Only one study with reported dose was available.

Justification for selection of acute toxicity – dermal endpoint
Only one study was available.

Justification for classification or non-classification

Oral:

The oral LD50 in the rats is 200 mg/kg bw (Bayer AG, 1978) and 240 mg/kg bw (Younger Laboratories Inc., 1977a).

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and mixtures the test substance is classified asAcute Tox. 3 H301 Toxic if swallowed according to Regulation (EC) No 1272/2008 criteria (T; R25 Toxic if swallowed according to DSD criteria).

Dermal:

The LD50 following dermal application to rabbits ranges between 200 and 316 mg/kg bw (Younger Laboratories Inc., 1977).

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and mixtures the test substance is classified asAcute Tox. 3 H311 Toxic in contact with skinaccording to Regulation (EC) No 1272/2008 criteria (T; R24 Toxic in contact with skin according to DSD criteria).

Inhalation:

Not classified. The LC50 was not determined in any of two inhalation studies (Younger Laboratories Inc. , 1977;BASF AG: Zeller H, Oettel H, 1965).