Hydrazine

Endpoint summary

Description of key information

Hydrazine is corrosive or irritating to the skin of rabbits when applied as 55 % solution or 35 % solution, respectively; in diluted form (5% solution) it causes no irritation to the skin of rabbits and none to the eye of rabbits (Bayer 1988, BUA 1996).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study, GLP, TS 5 % in water

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: adult
- Weight at study initiation: 3.1-3.3 kg
- Housing: individual
- Diet ad libitum
- Water . ad libitum):
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

other: diluted in water to yield a 5 % solution

Controls:

yes

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 animals 1 eye as the test eye the other served as control

Details on study design:

Comment: rinsed after (see exposure time)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: score = 0 at any time point

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: score = 0 at any time point

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: score = 0 at any time point

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: score = 0 at any time point

Irritant / corrosive response data:

there were no irritational effects observed in none of the animals in test

Other effects:

no other effects were reported

There were no irritational effects observed in none of the animals in test.

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

5 % hydrazine solution was evaluated as non-irritating to the eyes of rabbits when tested according to OECD TG 405.(Bayer AG 1988).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin:

Rabbits were testd with 500 µl of an aquous solution containing 5 % hydrazine for skin irritation according to OECD TG 404. the test substance was evaluated to be non-irritating (Bayer 1988). 35 % Hydrazine solution was tested for its potential to induce dermal corrosion according to the Transportation Regulations for shippers and GLP and was evaluated to be not corrosive but shows irritating effects which were only partly reversible within the observation time of 72 hours (Mobay Chemical Corporation 1984). Application of 55 % hydrazine solution to the clipped skin of rabbits for 4 hours showed the corrosive property of 55 % hydrazine solution (Otsuka Chem Comp. 1978)

The available data show that the effect on the skin changes from non-irritation to irritation and corrosion with increase in the concentration range.

Thus it is plausible that hydrazine can be corrosive at high concentrations.

Eye:

5 % hydrazine solution was evaluated as non-irritating to the eyes of rabbits when tested according to OECD TG 405.(Bayer AG 1988)

Justification for selection of skin irritation / corrosion endpoint:
There are 3 reliable studies available with increasing concentrations ranging between 5 and 55 % and evaluated with Klimisch score 1 and 2.

Justification for selection of eye irritation endpoint:
This is the only availble study which is performed according to the respective guideline and under GLP condions. Therefore is is evaluated with Klimisch score 1

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Under Regulation No 1272/2008 (GHS) the substance is classified as Skin corrosion class 1B, Hazard Statement H314: causes severe skin burns and eye damage: C >= 10 %;

Skin Irritation class 2, Hazard Statement H315: causes skin irritation: 3% <= C < 10, Eye Irritation class, Hazard Statement H319 causes severe eye irritation: 3 % <= C <10 %

In general, this classification is in line with the available data.