2,2'-azobis[2-methylpropionamidine] dihydrochloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

2,2’-Azobis(2-amidinopropane) dihydrochloride is expected not to be acute dermal toxic because the analogue 2,2’-Azobis(2-amidinopropane) sulfate has not shown acute dermal toxicity properties in a well performed study. The source chemical 2,2’-Azobis(2-amidinopropane) sulfate is sufficiently similar to read-across towards 2,2’-Azobis(2-amidinopropane) dihydrochloride.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-Azobis(2-amidinopropane) sulfate

IUPAC Name:

2,2'-Azobis(2-amidinopropane) sulfate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): 2,2'-Azobis (2-amidinopropane) sulfate
- Molecular formula (if other than submission substance): C8H20N6O4S
- Molecular weight (if other than submission substance): 296,347 g/mol
- Smiles notation (if other than submission substance): OS(O)(=O)=O.CC(C)(\N=N\C(C)(C)C(N)=N)C(N)=N
- InChl (if other than submission substance): InChI=1S/C8H18N6.H2O4S/c1-7(2,5(9)10)13-14-8(3,4)6(11)12;1-5(2,3)4/h1-4H3,(H3,9,10)(H3,11,12);(H2,1,2,3,4)
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: solid

Purity/impurities

The impurities in the target substance do not indicate toxicological relevence to this endpoint. The impurities are all below 1 %.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 207 to 300 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: aquesous methylcellulose 1%

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 %
- Type of wrap if used: aluminium foil, held in place with impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- suspended in vehicle
- Amount(s) applied (volume or weight with unit): 6.3 ml/kg bw
- Concentration (if solution): 60 % w/v suspension
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 6.3 ml/kg bw
- Concentration (if solution): 60 % w/v suspension

Duration of exposure:

24 hours

Doses:

3.78 g /kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

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

Statistics:

No statistics necessary

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 780 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Local dermal reactions at the site of application included slight to well-defined erythemaof a focal nature in nine animals between one and four days after treatment. This was accompanied by slight oedema in six animals between one and four days after tre

Gross pathology:

Terminal autopsy findings were normal

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

For 2,2’-Azobis(2-amidinopropane) sulfate an in vivo study is available showing no dermal toxicity up to the dose of 3780 mg/kg bw.

Executive summary:

For 2,2’-Azobis(2-amidinopropane) sulfate an in vivo study is available showing no dermal toxicity up to the dose of 3780 mg/kg bw.