1,4-dimethylpiperazine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-11 - 1990-10-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dimethylpiperazine

EC Number:

203-412-0

EC Name:

1,4-dimethylpiperazine

Cas Number:

106-58-1

Molecular formula:

C6H14N2

IUPAC Name:

1,4-dimethylpiperazine

Details on test material:

- Name of test material (as cited in study report): Jeffcat DMP

Specific details on test material used for the study:

- Name of test material (as cited in study report): 6398-14-20
- Physical state: clear, pale yellow liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: #90-006
- Stability under test conditions: No apparent change in the physical state of the test article during administration
- Other: gravity: 0.852 g/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: Males 2.271-2.795 kg; Females: 2.092-2.420 kg
- Fasting period before study: no data
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Rabbit Ration H.F. R, ad libitum,
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk (clipped free of fur)
- Type of wrap if used: The animals were wrapped with rubber dam and an elastic bandage to retard evaporation.

REMOVAL OF TEST SUBSTANCE: no washing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg

Duration of exposure:

24h

Doses:

3000 mg/kg

No. of animals per sex per dose:

10 (5 males and 5 females)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 000 mg/kg bw

Mortality:

Females: 2/5 died during 1st day observation
Males: 3/5 died during 1st day observation

Clinical signs:

other: Decreased activity, decreased muscle tone, abnormal stance, abnormal gait, immediate post-dose vocalization, necrosis and sloughing of the skin at the application site were also observed throughout the study.

Body weight:

other body weight observations

Remarks:

Mean bodyweight of males : 2483g (initial) - 2719g (final). Mean bodyweight of females : 2304g (initial) - 2672.7g (final).

Gross pathology:

Necropsy of the animals dying on study included pale and/or mottled liver, dark red or pale lungs, mottled lungs, clear or red oral and/or nasal discharge and severe irritation of underlying muscle at the application site.
Terminal necropsy of the remaining animals revealed no visible lesions.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the observations made in the acute dermal exposure toxicity study in rabbits where animals were exposed to 3000 mg/kg bw of '6398-17-20' (name indicated in the report), the estimated dermal LD50 was determined to be 3000 mg/kg. Based on these results and according to the criteria laid down in the CLP Regulation, the substance is not to be classified as acute dermal toxicant.