Reaction mass of 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 June 2016 - 20 July 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane

EC Number:

908-084-9

IUPAC Name:

bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: Between 218 g and 244 g
- Housing: Individual caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 – 24.1°C
- Humidity (%): 30 – 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: 30 June 2016 To: 20 July 2016

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

The back of each animal was shaved (approximately 10 % area of the total body surface) approximately 24 hours prior to treatment. The test item was applied as a single dose, moistened with water to the shaved skin and remained in contact with the skin for the 24-hour exposure period. Sterile gauze pads were placed on the skin of rats to cover the test item. These gauze pads were kept in contact with the skin using a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, the treated area of skin with the test item was washed with water of body temperature.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, skin irritation, body weight,

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Test item did not cause mortality at the dose level of 2000 mg/kg bw.

Clinical signs:

other: Systemic Clinical Signs: There were no systemic clinical signs noted in any animal throughout the study. Local Dermal Signs: The test item coloured the surface of the skin to bluish for 3-6 days. No adverse local dermal signs were observed after treatment

Gross pathology:

There was no evidence of any gross changes at a dose level of 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item B331 was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats.