potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]

Eye irritation

Administrative data

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:

comparable to guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Before OECD guideline 405 was established, eye irritation was tested using an internal method (BASF test).

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

- Principle of test: in vivo test with rabbits
- Short description of test conditions: were introduced into the conjunctival sac of the rabbit eye and distributed uniformly over the surface of the eye.
- Parameters analysed / observed: Local irritant effects

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was performed

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexylhydroxydiazene 1-oxide, potassium salt

EC Number:

613-953-8

Cas Number:

66603-10-9

Molecular formula:

C6H11KN2O2

IUPAC Name:

Cyclohexylhydroxydiazene 1-oxide, potassium salt

Test material form:

liquid

Details on test material:

Xyligen 30F is a 30% aqueous solution of K-HDO.

Specific details on test material used for the study:

Xyligen 30 F has been applied undiluted.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Source: obtained commercially
- Sex: male / female
- Weight at study initiation: 2.75 kg (mean value)
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 50 mm³
- Concentration (if solution): the substance has been applied undiluted.

VEHICLE
- no vehicle used

Duration of treatment / exposure:

8 days

Observation period (in vivo):

1 hour, 24 hours, 8 days

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing is not mentioned in the report

SCORING SYSTEM:
- BASF scoring system: Explanation of signs:
0 = non-irritant
+/++ = slight / severe
R = reddening
E = edema
C = clouding of the cornea
S = scaling

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

conjunctivae score

Remarks:

Chemosis

Basis:

mean

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

The instillation of about 50 mm³ of the undiluted product into the conjunctival sac of the rabbit eye brought about marked reddening and relatively severe swelling of the conjunctiva, together with mucosal bleeding and blurred clouding of the cornea. The inflammatory changes were reversible over the course of 8 days.

Other effects:

No other effects observed.

Any other information on results incl. tables

The average score between 24h, 48h and 72h cannot be calculated because the values for 48h and 72h are not documented. Therefore, the 24h value has to be used instead. Since this 24h score of 1,5 is considered to correspond to an OECD score of 3 and since bleeding was observed also 24 hours after exposure the 30% K-HDO is considered to cause risk for serious damage to eye.

Applicant's summary and conclusion

Conclusions:

K-HDO 30 % in water is considered to cause serious damage to eyes.

Executive summary:

The instillation of about 50 mm³ of the undiluted product into the conjuctival sac of the rabbit eye brought about marked reddening and relatively severe swelling of the conjunctiva, together with mucosal bleeding and blurred clouding of the cornea. The inflammatory changes were reversible over the course of 8 days.