Amines, C12-14-tert-alkyl, compds. with 1-[2-[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]diazenyl]-2-naphthalenol 1-[2-[2-hydroxy-4(or 5)-nitrophenyl]diazenyl]-2-naphthalenol chromium complexes

Endpoint summary

Description of key information

The oral LD50 value in rat is > 5000 mg/kg bw (OECD 401, GLP).
The dermal LD50 in rat is > 2000 mg/kg bw (OECD 402, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15.07.-29.07.1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG
- Age at study initiation: 7 weeks
- Fasting period before study: Animals were fasted overnight prior to dosing until 15 minutes after administration of the test substance.
- Housing: polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20 °C
- Humidity (%): 60-90%
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: 15 - 29 July 1988

Route of administration:

oral: gavage

Vehicle:

other: 1% aqueous methylcellulose

Details on oral exposure:

Amount of vehicle: 20 ml/ kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations were performed once on the day of dosing (due to the late dosing time no further periodic observations were performed)
and once daily thereafter for 14 days (inadvertently, the observations on day 5 were missed). Any signs of toxicity were recorded along with the time of onset and duration. Individual bodyweights were measured weekly.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occured.

Mortality:

No mortality occured.

Clinical signs:

other: No signs of toxicity were observed during the 14 day observation period.

Gross pathology:

Macroscopic examination of all animals at termination did not reveal any changes that there considered to have arisen as a result of treatment.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09.08.-23.08.1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, FRG
- Age at study initiation: 10 weeks
- Housing: polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%): 60-85%
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 09 - 23 August 1988

Type of coverage:

semiocclusive

Vehicle:

other: 1% aqueous methyl cellulose

Details on dermal exposure:

TEST SITE
The test substance was suspended in 1% aqueous methyl cellulose and spread on a surgical gauze (5x5 cm and 5x3.5 cm for males and females, respectively). This was fixed to, successively, aluminium foil and flexible bandage with drops of vaseline. This patch was then applied to the clipped area of each animal and fixed with adhesive tape.

REMOVAL OF TEST SUBSTANCE
After 24 hrs of exposure, the semi-occlusive bandage was removed and the remaining test substance was gently removed with tissues, moistened with tap water. The day of application of the test substance was considered as day 0.

TEST MATERIAL
The dose level was 2000 mg/kg bw and the dose volume was 20 ml/kg bw.
- Constant volume or concentration used: yes

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw (males and females)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration. Individual bodyweights were measured weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: In addition, observations regarding changes of the treated surface were performed following bandage removal and on days 4, 7 and 14. At the end of the study (day 14) all animals were anaesthetised by CO2/O2 inhalation, subsequently killed by CO2 and subjected to necropsy.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of toxicity were oberved during the 14 day observation period (with the exception of one animal showing hypothermia at the time of bandage removal, most probably due to tight application of the bandage). Following bandage removal and until day 4

Gross pathology:

Macroscopic examination at necropsy of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Oral route:

In an acute oral toxicity study according to OECD TG 401 and GLP (RCC NOTOX B.V. 1988), groups of fasted, young adult Wistar rats (5/sex) were given a single oral dose of the test substance in 1% methyl cellulose at 5000 mg/kg bw and consecutively observed for 14 days. No mortality occured and no signs of toxicity were observed during the 14 day observation period. Bodyweight development was not impaired.

The oral LD50 value was determined to be > 5000 mg/kg bw.

Inhalation route:

No experimental data is available on the UVCB substance itself. A reliable study is available for the organometallic UVCB part. It misses the salt formation with the branched alkylamine and is therefore only of supportive evidence. It shows that at least from the organometallic part, there is no hazard for acute inhalation toxicity at dust concentrations of up to 5 mg/m3 air.

Dermal route:

The acute dermal toxicity of the test substance at the limit dose of 2000 mg/kg bw, was studied in Wistar rats (5/sex) according to OECD TG 402 and GLP (RCC NOTOX B.V.a). There were no deaths and no systemic response to treatment in any animal throughout the study. No dermal reactions were observed in any animal during the study. Two male animals showed a temporary bodyweight decrease during the first week of observation. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study. Based on these results the acute lethal dermal dose to rats of the test substance was demonstrated to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008.