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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Reference substance name:
L9-11 phthalate
IUPAC Name:
L9-11 phthalate
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system 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.