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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Immunotoxicity

Currently viewing:

Administrative data

Endpoint:
immunotoxicity
Remarks:
acute
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1970
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: early study; non-GLP; poor sample characterisation, short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Animals were treated once by intrapertoneal injection. Thereafter they were exposed to UV radiation for twice 6 hours with an interval of 18 hours. An observation period of 7 days followed. A second group was treated in the same way but not exposed to UV-radiation.
GLP compliance:
no
Remarks:
predates GLP regulation
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fluoreszenzrot GG
IUPAC Name:
Fluoreszenzrot GG
Details on test material:
no data provided

Test animals

Species:
mouse
Strain:
not specified
Sex:
female
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: sesame oil
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
single injection
Doses / concentrations
Remarks:
Doses / Concentrations:
15000 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, sham-exposed

Examinations

Observations and clinical examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

BODY WEIGHT: No data
Sacrifice and pathology:
no data
Cell viabilities:
not applicable
Humoral immunity examinations:
not applicable
Specific cell-mediated immunity:
not applicable
Non-specific cell-mediated immunity:
not applicable
Other functional activity assays:
no data
Other examinations:
no data
Positive control:
no

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Gross pathological findings:
not specified

Specific immunotoxic examinations

Cell viabilities:
not specified
Humoral immunity examinations:
not specified
Specific cell-mediated immunity:
not specified
Non-specific cell-mediated immunity:
not specified
Other functional activity assays:
not specified
Other findings:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Remarks:
light sensitisation of the skin
Effect level:
15 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female

Applicant's summary and conclusion

Conclusions:
There was no indication of a light sensitising effect of the test material
Executive summary:

Five femal mice per group were treated once by intrapertoneal injection at a dose of 15000 mg/kg bw. Immediately thereafter they were exposed to intense UV radiation for twice 6 hours with an interval of 18 hours. An observation period of 7 days followed.

A second group was treated in the same way but not exposed to UV-radiation.

The treatment did not produce any indication of a light sensitising effect of the test material.