Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.

Cross-referenceopen allclose all

Data source

Materials and methods

Principles of method if other than guideline:

The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. Observations were recorded up to 72 hours after the final dose.

GLP compliance:

no

Limit test:

no

Test material

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

No additional data

Administration / exposure

Type of coverage:

other: ear- open; intact and abraded abdomen- occluded

Vehicle:

unchanged (no vehicle)

Details on exposure:

The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were graded

Analytical verification of doses or concentrations:

no

Details on analytical verification of doses or concentrations:

Not applicable

Duration of treatment / exposure:

24 hours

Frequency of treatment:

Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily
applications to the abraded abdominal site.

No. of animals per sex per dose:

1

Control animals:

no

Details on study design:

The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The abdomen of the rabbit was shaved with a straight razor at least three days prior to test initiation. The animal was
bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours
after application the bandage was removed and the application sites were graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. The study was terminated 72 hours after the final dose.

Positive control:

None

Examinations

Observations and examinations performed and frequency:

Twenty four hours after application the bandage was removed and the application sites were graded. Observations were recorded out to 72 hours after the last dose.

Sacrifice and pathology:

No data

Other examinations:

None

Statistics:

None

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

effects observed, treatment-related

Mortality:

no mortality observed

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not examined

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

not examined

Clinical biochemistry findings:

not examined

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

not examined

Gross pathological findings:

not examined

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

The animal survived the test period. No clinical signs indicative of systemic toxicity were observed.

No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.

Target system / organ toxicity

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.

Executive summary:

The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.