6-nonyl-1,3,5-triazine-2,4-diamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no information available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

similar to version of May 1982.

Deviations:

yes

Remarks:

Only two animals per sex per dose level and half of the animals received the material on abraded skin.

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

6-nonyl-1,3,5-triazine-2,4-diamine

EC Number:

227-645-2

EC Name:

6-nonyl-1,3,5-triazine-2,4-diamine

Cas Number:

5921-65-3

Molecular formula:

C12H23N5

IUPAC Name:

6-nonyl-1,3,5-triazine-2,4-diamine

Test material form:

solid: bulk

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.43 to 2.95 kg
- Fasting before dosing: no
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C

Administration / exposure

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk
- % coverage: 10%
- Type of wrap if used: the treated area was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0, 0.7, 1.4, 2.8 g/kg bw
- Constant volume used: yes
- For solids, paste formed: partly solution, partly suspension

VEHICLE
- Amount(s) applied (volume or weight with unit): 9 mL/kg bw
Half the number of animals received the material on the intact skin, the other half on the abraded skin.

Duration of exposure:

24 hours

Doses:

0.0, 0.7, 1.4, 2.8 g/kg bw

No. of animals per sex per dose:

2

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: food consumption, water intake, haematology, histopathology (heart, liver, kidney, spleen, treated and untreated skin)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 800 mg/kg bw

Based on:

act. ingr.

Mortality:

One rabbit treated with 1.4 g/kg bw and one treated with 2.8 g/kg bw died during the observation period. Both deaths were not regarded as treatment related.

Clinical signs:

other: During or at the end of the 24-hour exposure period the skin of the rabbits of the hightest dose group showed slight to moderate erythema. In the course of the subsequent observation period, the rabbits of the hightest dose group showed slight to moderate

Gross pathology:

At necropsy pathological changes related to treatment were observed only in the skin of the rabbits of the high dose group. They consisted of slight to moderate scaliness.

Other findings:

Food and water intake and haematological data of the rabbits of the test group were comparable with those of controls.
At microscopic examination, dose-related histopathological changes were found only in skin. They were characterised by acanthosis, hyperkeratosis and signs of inflammation in the dermis. The severity of the skin lesions was of a mild degree in animals of the hightest dose group.
Microscopic examination of the liver, kidneys, heart and spleen did not reveal abnormalities that could be related to treatment.

Any other information on results incl. tables

The animal of the hightes dose group that died during the observation period showed smal haemorrhagic erosions in the stomach and marked lobular bronchopneumonia.

Examination of the animal of the intermediate dose group that died during the observation period did not provide any information to establish the cause of death.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of Caprinoguanamine in rabbits was > 2800 mg/kg bw.

Executive summary:

In an acute dermal toxicity study similar to OECD guideline 402, 8 male and 8 female adult New Zealand White albino rabbits were divided into four dose groups and received doses of 0.0, 0.7, 1.4, 2.8 g/kg bw Caprinoguanamine in propylene glycol half of the animals on intact skin and half on the animals on abraded skin. After treatment the animals were observed for two weeks with regard to general appearance and behaviour, mortality, local skin reactions, growth, and food and water intake. At the end of the experimental period examinations were carried out for possible haematological changes and histopathological changes.

During or at the end of the 24-hour exposure period the skin of the rabbits of the highest dose group showed slight to moderate erythema. In the course of the subsequent observation period, the rabbits of the highest dose group showed slight to moderate scaliness of the treated skin. One rabbit treated with 1.4 g/kg bw and one treated with 2.8 g/kg bw died during the observation period. Both deaths were not regarded as treatment related.

Body weight gain, food and water intake and haematological data of the rabbits of the test group were comparable with those of controls. At microscopic examination, dose-related histopathological changes were found only in skin. They were characterised by acanthosis, hyperkeratosis and signs of inflammation in the dermis. The severity of the skin lesions was of a mild degree in animals of the highest dose group.

Microscopic examination of the liver, kidneys, heart and spleen did not reveal abnormalities that could be related to treatment.

Dermal LD50 (rabbit, females/males) > 2800 mg/kg bw