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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1970
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Experimental data reported in peer reveiwed journal. However, study not of required duration to comply with current test guidelines for a sub-acute / sub-chronic study and few details on methods / results are available.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1970

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To assess gross skin damage & provide skin samples for microscopic examination after 15 (3 X 5)d application to shaved skin of rabbits
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on exposure:
no data except shaved area was from shoulders to hips & animals were shaved weekly.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
3 weeks
Frequency of treatment:
Daily 5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
1 ml
Basis:
nominal per unit area
No. of animals per sex per dose:
1 male & 1 female
Control animals:
not specified
Details on study design:
no data
Positive control:
N/A

Examinations

Observations and examinations performed and frequency:
Daily visual assessment of gross skin damage
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (see table) / No / No data: yes
HISTOPATHOLOGY: Yes (see table) / No / No data: yes, skin samples
Other examinations:
no data
Statistics:
N/A only 1 male & 1 female

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not examined
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
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not examined

Effect levels

Dose descriptor:
other: irritant to skin
Effect level:
1 other: ml/application site/animal
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Non irritant to skin

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study L9-11P was not irritant to rabbit skin when 1 ml applied daily for 5/days/week for 3 weeks.