Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- review article or handbook
- Title:
- Hydrazin, Hydrazinhydrat und Hydrazinsulfat, BUA-Stoffbericht 205
- Author:
- Beratergremium Umweltrelevante Altstoffe (BUA)
- Year:
- 1 996
- Bibliographic source:
- S. Hirzel Wissenschaftliche Verlagsgesellschaft
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrazine
- EC Number:
- 206-114-9
- EC Name:
- Hydrazine
- Cas Number:
- 302-01-2
- Molecular formula:
- H4N2
- IUPAC Name:
- hydrazine
- Details on test material:
- IUCLID4 Test substance: other TS: 50 g hydrazine ad 1000 ml water
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 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
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: diluted in water to yield a 5 % solution
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 µl of the hydrazine solution (5%) - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 14 d
- Number of animals:
- 6 rabbits: one side fo the back as test side and the other side served as control
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
-covered with a guaze patch held inplace with a plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean erythema score/ 4 animals over 14 days
- Basis:
- mean
- Time point:
- other: at the end of the observation period of 14 days
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: mean erythema score /animal over 14 days
- Basis:
- mean
- Time point:
- other: at the end of the observation period
- Score:
- ca. 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: mean erythema score/animal over 14 days
- Basis:
- mean
- Time point:
- other: at the end of the observation period
- Score:
- ca. 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: during the 14 day observation period
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No edemas were observed in none of the treated animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Other effects:
- no other effects were reported
Any other information on results incl. tables
Slight erythema (sore 1 of max.4) in 6/6 at 24 h, but reversible in 4/6
at 48 h; total recovery after 14 days
no edema.
Mean irritation index:
Erythema: 0.6
Edema: 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Executive summary:
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.
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