Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
genetic toxicity in vivo, other
Remarks:
Dominant lethal test
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
Deviations:
yes
Remarks:
No positive controls used; 3 separate studies performed
GLP compliance:
no
Remarks:
Study pre-dates GLP regulations
Type of assay:
rodent dominant lethal assay

Test material

Constituent 1
Reference substance name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
EC Number:
307-259-1
EC Name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
Cas Number:
97592-62-6
Molecular formula:
not available
IUPAC Name:
Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
Test material form:
solid
Specific details on test material used for the study:
- Name as used in the study report: FAT 60 149/B

Test animals

Species:
mouse
Strain:
Tif:MAGf
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: closed SPF breeding colony
- Age at study initiation: 2-3 months
- Weight at study initiation: 28-53 g
- Diet: standard laboratory diet (NAFAG No.890)
- Water: ad libitum:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 34-78
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Polyethylene glycol 400
Details on exposure:
The substance was administered orally by intubation in single doses of 666 and 2000 mg/kg to each 20 males. The control group was treated with the vehicle only. The females remained untreated.
Duration of treatment / exposure:
Singe doses
Frequency of treatment:
Once
Post exposure period:
6 hours
Doses / concentrationsopen allclose all
Dose / conc.:
666 mg/kg bw (total dose)
Dose / conc.:
2 000 mg/kg bw (total dose)
No. of animals per sex per dose:
20 males
Control animals:
yes, concurrent vehicle
Positive control(s):
no

Examinations

Details of tissue and slide preparation:
The number of live embryos and embryonic deaths were listed. In addition, the uteri were placed in a solution of ammonium sulphide in order to detect sites of early embryonic resorptions.
Statistics:
To compare the totals of the number of implantations indicating possible pre-implantation losses - the t-test or Mann-Whitney's U-test was used. The totals of the numbers of mated.and pregnant dams or embryonic deaths were compared with the aid of the Χ2-test or - Fisher's exact test.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not examined
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined
Additional information on results:
In the first study, the date on the mating ratio and the number of implantations were comparable in all groups. The data on embryonic deaths showed a statistically significant increase in the high-dose group in the second (14.5%) and the third (16.3%) mating periods in comparison to the respective controls (7.5% and 6.9%) (p<0.01). In the second study, the findings made in first study were not reproduced. In this study, in the second mating period, there was a statistically significant increase in the number of embryonic deaths in the low-dose group in comparison with the control (10.8%; control 4.9%) (p<0.01). In addition, a statistically significantly lower rate of pregnancies was found in the control group (69.2%) during the third period, in comparison with the respective treatment groups (>90%). In the third study, the statistically significant finding made in both, the 1 and the 2 study were not reproduced. In this study, only in the low-dose group during the first period was a lower number of implantations (mean value 9.84) found than in the controls (mean value 11.1).

Since the deviations observed in the three studies were each only reproducible on the individual investigations and not in one or both of the others, they can be regarded as purely fortuitous and the results in their entirety therefore cannot be interpreted as evidence of dominant lethal effects in the progeny of male mice treated with the test substance.

Applicant's summary and conclusion