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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
repeated dose toxicity: other route
Remarks:
other: Combined repeated dose repro-devp. Screen
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
publication
Title:
Histopathological effects of maternal hair dye use on the cornea
Author:
Hulya Erbagci, Ibrahim Erbagci, Ibrahim Sari, Nese Kizilkan, Cahit Bagci, Oguzhan Saygili, Erdem Gumusburun and Mehmet Ozaslan
Year:
2010
Bibliographic source:
African Journal of Biotechnology Vol. 9 (25), pp. 3944-3948, 21 June, 2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Principles and Guidelines for the Use of Animals in Research, Testing, and Education issued by the New York Academy of Sciences’ Committee on Educational on Animal Research (Committee on Educational Programmes in Laboratory Animal Science, 1991).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-nitro-p-phenylenediamine
EC Number:
226-164-5
EC Name:
2-nitro-p-phenylenediamine
Cas Number:
5307-14-2
Molecular formula:
C6H7N3O2
IUPAC Name:
2-nitrobenzene-1,4-diamine
Details on test material:
- Name of test material (as cited in study report):2-nitro-p-phenylenediamine- Substance type:Organic- Physical state:Solid

Test animals

Species:
rat
Strain:
other: Wistar Albino
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALSSource: No dataAge at study initiation: No dataWeight at study initiation: No data Fasting period before study: No dataHousing: metal cagesDiet (e.g. ad libitum):No dataWater (e.g. ad libitum):No dataAcclimation period: No dataENVIRONMENTAL CONDITIONSTemperature (°C): 20 - 22°CHumidity (%): No dataAir changes (per hr):No dataPhotoperiod (hrs dark / hrs light):12 h light period.IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
other: Subcutaneous exposure between 7th and 15th days of gestation
Vehicle:
not specified
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Subcutaneous exposure between 7th and 15th days of gestation
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:150mg/kgbw/day
No. of animals per sex per dose:
10 females and 30 neonates
Control animals:
yes
Details on study design:
6 control rats

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes / No / No data: No dataDETAILED CLINICAL OBSERVATIONS: Yes / No / No data: No dataDERMAL IRRITATION (if dermal study): Yes / No / No data: No dataBODY WEIGHT: Yes / No / No data: No dataFOOD CONSUMPTION: No dataFOOD EFFICIENCY: No dataWATER CONSUMPTION: Yes / No / No data: No dataOPHTHALMOSCOPIC EXAMINATION: Yes / No / No data : YesTime schedule for examinations: 20th day of gestationDose groups that were examined:Thirty fetuses HAEMATOLOGY: Yes / No / No data: No data.CLINICAL CHEMISTRY: Yes / No / No data: No dataURINALYSIS: Yes / No / No dataNo dataNEUROBEHAVIOURAL EXAMINATION: Yes / No / No data: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (see table) / No / No data: No dataHISTOPATHOLOGY: Yes (see table) / No / No data: Yes for 30 fetuses
Other examinations:
Corneal examinations of the fetuses
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
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:
effects observed, treatment-related
Description (incidence and severity):
Histopathological examinations of the corneas by light Microscope was performed for 30 fetuses after sacrifice
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Corneal histopathological changes were seen in 76.6% in Group II (2 NPPD) (23 of 30 rats)
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
effects observed, treatment-related
Details on results:
Histopathology:Corneal histopathological changes were seen in 83.3% rats administered 2 NPPD (25 of 30 rats). While there were endothelial proliferation in 3 eyes (10%) of group II (2NPPD), Stromal proliferation of corneal were seen in in 6 eyes (20%) of Group II (2 NPPD).Corneal epithelial proliferation was inspected in 2NPPD [5 eyes (16.7%)]

Effect levels

Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day
Based on:
test mat.
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The aim of this study is to investigate and compare the histopathological effects of hair dye additives, 2-nitro-p-phenylendiamin (2NPPD) on cornea of neonates frompregnant rats that have been administered these additives subcutaneously.Ten rats received 150 mg/kg/day 2NPPD (Group II) injections subcutaneously between 7th and 15th gestational days.No sign of toxicity was observed during the treatment and there was no gross abnormality.The NOAEL for the female rats and LOAEL for the fetuses can be considered as 150mg/kgbw/day
Executive summary:

The aim of this study is to investigate and compare the histopathological effects of hair dye additives, 2-nitro-p-phenylendiamin (2NPPD) on cornea of neonates from pregnant rats that have been administered these additives subcutaneously.

Ten rats received 150 mg/kg/day 2NPPD (Group II) injections subcutaneously between 7th and 15th gestational days.

No sign of toxicity was observed during the treatment and there was no gross abnormality.

Histopathological examinations of the corneas by light Microscope was performed for 30 fetuses after sacrifice. Corneal histopathological changes were seen in 76.6% in Group II (2 NPPD) (23 of 30 rats). Corneal histopathological changes were seen in 83.3% rats administered 2 NPPD (25 of 30 rats). While there were endothelial proliferation in 3 eyes (10%) of group II (2NPPD), Stromal proliferation of corneal were seen in in 6 eyes (20%) of Group II (2 NPPD).Corneal epithelial proliferation was inspected in 2NPPD [5 eyes (16.7%)].

 

The NOAEL for the female rats and LOAEL for the fetuses can be considered as 150mg/kgbw/day