Cyclohex-1,2-ylenediamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

no weighing was performed; exposed area of the low dosed animals only 4% of the total body surface

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohex-1,2-ylenediamine

EC Number:

211-776-7

EC Name:

Cyclohex-1,2-ylenediamine

Cas Number:

694-83-7

Molecular formula:

C6H14N2

IUPAC Name:

cyclohexane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): 1,2-Diaminocyclohexan
- Physical state: liquid
- Analytical purity: 98%
- pH: 14

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Sulzfeld, D
- Mean weight at study initiation: males 193 g, females 164 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal and lateral parts of the trunk
- % coverage: 1600-3200 mg/kg bw: ca. 42 cm² -->10% of the total body surface; 1000 mg/kg bw: ca. 12 cm = ca. 4% of the total body surface (considering a mean body weight of 185 g and the formula: body surface area = 10 * (weight (g) *exp 0.67))
- Type of wrap if used: aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and water/Lutrol

Duration of exposure:

24 h

Doses:

1000, 1600, 2000, 2500 and 3200 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: several times on the day of administration and at least once each workday; check for moribund and dead animals twice each workday and once on holidays; weighing after day 0 was not reported
- Necropsy of survivors performed: yes

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 870 mg/kg bw

Based on:

test mat.

95% CL:

1 700 - 2 050

Remarks on result:

other: LD50 for males: not calculated; LD50 for females: 1786 mg/kg bw

Mortality:

1000 mg/kg bw: 0 males and 0 females died
1600 mg/kg bw: 0 males and 1 females died within 24 hours
2000 mg/kg bw: 3 males and 4 females died; thereof, 5 animals died within 48 hours
2500 mg/kg bw: all animals died within 48 hours
3200 mg/kg bw: all animals died within 24 hours

Clinical signs:

other: other: screaming directly after application, high-stepping gait on the day of administration (>= 1600 mg/kg bw), strong apathy (not reversible at the 1600 mg/kg bw treatment, reversible within 6 days at the 1000 mg/kg bw treatment)

Gross pathology:

Animals that died: (right) heart dilatation, congestion hyperemia, pale liver and kidneys
Surviving animals: nothing abnormal observed

Other findings:

24 hours after application, animals showed formation of necrosis; within the observation period, open and moisted necrosis were observed (local concentration ranged from ca. 38 to 77 mg test substance/cm² skin for the 1600-3200 mg/kg bw treatment and ca. 83 mg/ cm² skin for the 1000 mg/kg bw treatment due to the smaller exposure area of this treatment)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the applied test condition the test substance has an LD50 value of 1870 mg/kg bw.

Executive summary:

In a study similar to OECD guideline 402, test substance was administered under occlusive conditions for 24 h to the skin of 5 male and 5 female Sprague-Dawley rats per dose group (1000, 1600, 2000, 2500 and 3200 mg/kg bw) . The LD 50 value was calculated to be 1870 mg/kg bw.