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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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)
Body weight:
weighing was not performed
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:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.