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REACH

Cuprate(4-), [C-(aminosulfonyl)-C-[[[2-[[4-chloro-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]sulfonyl]-29H,31H-phthalocyanine-C,C-disulfonato(6-)-N29,N30,N31,N32]-, sodium salts

EC number: 689-188-9 | CAS number: 149343-84-0

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Administrative data

Description of key information

Acute toxicity: oral

LD50: >2000 mg/kg bw (male/female Sprague -Dawley strain rat)

Acute toxicity: dermal

LD50: >2000 mg/kg bw (male/female Sprague-Dawley strain rat)

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:

27 April 1993 to 8 June 1993.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity"

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Method B1 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

No further details specified in the study report.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Specification
Male and female Sprague-Dawley strain rats were supplied by Charles River (UK) Ltd., Manston, Kent, U.K. At the start of the main study the males weighed 138 – 165 g, and the females 122 – 134 g, and were approximately five to eight weeks old. After a minimum acclimatization period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.

Husbandry
The animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 22 °C and relative humidity of 48 - 54%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in distilled water.

Doses:

Single dose: 2000 mg/kg

No. of animals per sex per dose:

Range-finding study: 2 (1 male/1 female)
Main Study: 10 (5 males/5 females)

Control animals:

Details on study design:

Range-finding Study
A range-finding study was performed to establish a dosing regime.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.

Main Study
Based on the results of the range-finding study a further group of animals was treated.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Preliminary study:

There were no deaths or clinical signs of toxicity.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

Blue-coloured urine was noted in all animals. Blue-coloured staining of the fur was noted in all animals. All animals recovered two days after dosing .

Body weight:

All animals showed expected gain in bodyweight during the study.

Gross pathology:

All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.

JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE RANGE-FINDING STUDY

Dose Level mg/kg	Animal Number & Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
Dose Level mg/kg	Animal Number & Sex	½	1	2	4	1	2	3	4	5
2000	1-0 Male	0	0	0	0	0	0	0	0	0
2000	2-0 Female	0	0	0	0	0	0	0	0	0

JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY

Dose Level mg/kg	Animal Number & Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
Dose Level mg/kg	Animal Number & Sex	½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	3-0 Male	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	3-1 Male	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	3-2 Male	0	0	Fs0	Fs0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	3-3 Male	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	3-4 Male	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	4-0 Female	0	0	Fs0	Fs0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	4-1 Female	0	0	0	Fs0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	4-2 Female	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	4-3 Female	0	0	Fs0	Fs DuB	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0
	4-4 Female	0	0	0	0	Fs DuB	Fs0	0	0	0	0	0	0	0	0	0	0	0	0

0 = no signs of systemic toxicity DuB = blue coloured urine

Fs = blue coloured staining of the fur

JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT GAIN IN THE MAIN STUDY

Dose Level mg/kg

Animal Number & Sex

Bodyweight (g) at Day

Bodyweight Gain (g) During Week

2000

3-0 Male

3-1 Male

3-2 Male

3-3 Male

3-4 Male

4-0 Female

4-1 Female

4-2 Female

4-3 Female

4-4 Female

161

150

165

138

164

122

132

130

134

128

226

238

240

202

287

178

190

179

175

171

287

290

308

254

295

206

221

203

195

188

JPR BLUE 100: ACUTE ORAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY

Dose Level mg/kg	Animal Number & Sex	Time of Death	Macroscopic Observations
2000	3-0 Male	Killed day 14	Kidneys: dark blue coloured outer cortex region
	3-1 Male	Killed day 14	Kidneys: dark blue coloured outer cortex region
	3-2 Male	Killed day 14	Kidneys: dark blue coloured outer cortex region
	3-3 Male	Killed day 14	Kidneys: dark blue coloured outer cortex region
	3-4 Male	Killed day 14	Kidneys: dark blue coloured outer cortex region
	4-0 Female	Killed day 14	Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining
	4-1 Female	Killed day 14	Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining
	4-2 Female	Killed day 14	Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining
	4-3 Female	Killed day 14	Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining
	4-4 Female	Killed day 14	Kidneys: dark blue coloured outer cortex region Non-glandular epithelium of stomach: blue coloured staining

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LDso) of the test material, JPR BLUE 100, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity" referenced as Method B1 in Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/ 548/ EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/ EEC (as adapted to technical progress by Commission Directive 91/325/ EEC).

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. Blue-coloured urine was noted in all animals.

All animals recovered two days after dosing.

All animals showed expected gain in bodyweight during the study.

All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.

The acute oral median lethal dose (LD50) of the test material in the Sprague -Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labelling regulations.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: 2 000 mg/kg bw
Quality of whole database:: K1

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:

25 May 1993 to 8 June 1993 .

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity"

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Method B3 in Commission Directive 92/ 69/ EEC (which constitutes Annex V of Council Directive 67/ 548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

No further details specified in the study report.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Specification
Five male and five female Sprague-Dawley strain rats were supplied by Charles River (UK) ltd., Manston, Kent,U. K. At the start of the study the males weighed 204 – 226 g, and the females 200 – 222 g, and were approximately ten to fourteen weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.

Husbandry
The animals were housed in suspended polypropylene cages furnished with softwood sawdust. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 23 °C and relative humidity of 48 - 54%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 5 cm x 4 cm.
A group of five male and five female rats were treated with the test material at a dose level of 2000 mg/kg.
The appropriate amount of the undiluted test material, as received, was pre-weighed into a glass vial. The test material was then applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) which had previously been moistened with distilled water. A piece of surgical gauze was placed over the treatment area and semi -occluded with a piece of self-adhesive bandage (HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.
Shortly after dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the rest of the study .

Duration of exposure:

24 hours

Doses:

Single dose of 2000 mg/kg

No. of animals per sex per dose:

10 animals (5 males/5 females)

Control animals:

Details on study design:

The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
The animals were also observed for any dermal reactions after removal of the dressings and subsequently once daily for the remainder of the study.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

No signs of systemic toxicity were noted during the study. Blue coloured staining of the fur was commonly noted.

Body weight:

All animals showed expected gain in bodyweight during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of skin irritation were noted during the study. Blue coloured staining of the treatment site was commonly noted.

JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA

Dose Level mg/kg	Animal Number & Sex	Effects Noted After Initiation of Exposure (Hours)				Effects Noted After Initiation of Exposure (Days)
Dose Level mg/kg	Animal Number & Sex	½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Male	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	1-1 Male	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	1-2 Male	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0
	1-3 Male	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	1-4 Male	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	2-0 Female	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	2-1 Female	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	2-2 Female	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0
	2-3 Female	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0
	2-4 Female	0	0	0	0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	Fs0	0	0	0	0	0

0 = no signs of systemic toxicity

Fs = blue coloured staining of the fur

JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL DERMAL REACTIONS

Dose Level mg/kg

Animal Number & Sex

Observation

Effects Noted After Initiation of Exposure

(Days)

2000

1-0 Male

Erythema

Oedema

Other

STA

1-1 Male

Erythema

Oedema

Other

STA

1-2 Male

Erythema

Oedema

Other

STA

1-3 Male

Erythema

Oedema

Other

STA

1-4 Male

Erythema

Oedema

Other

STA

2-0 Female

Erythema

Oedema

Other

STA

2-1 Female

Erythema

Oedema

Other

STA

2-2 Female

Erythema

Oedema

Other

STA

2-3 Female

Erythema

Oedema

Other

STA

2-4 Female

Erythema

Oedema

Other

STA

STA = blue-coloured staining of the treatment site

0 = no signs of dermal irritation

JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT GAIN

Dose Level mg/kg

Animal Number & Sex

Bodyweight (g) at Day

Bodyweight Gain (g) During Week

2000

1-0 Male

1-1 Male

1-2 Male

1-3 Male

1-4 Male

2-0 Female

2-1 Female

2-2 Female

2-3 Female

2-4 Female

225

226

204

208

219

220

222

200

209

213

262

275

267

257

274

230

241

203

223

234

300

325

324

310

329

260

270

211

253

257

JPR BLUE 100: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT

INDIVIDUAL NECROPSY FINDINGS

Dose Level mg/kg

Animal Number & Sex

Time of Death

Macroscopic Observations

2000

1-0 Male

1-1 Male

1-2 Male

1-3 Male

1-4 Male

2-0 Female

2-1 Female

2-2 Female

2-3 Female

2-4 Female

Killed day 14

No abnormalities detected

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material, JPR BLUE 100, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol or risk phrase is required according to EEC labelling regulations.

Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 "Acute Dermal Toxicity" referenced as Method B3 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/ 548/ EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/ 548/EEC (as adapted to technical progress by Commission Directive 91/325/ EEC).

A group of ten animals (five males and five females) was given a single 24 -hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.

All animals showed expected gain in bodyweight during the study.

No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight. No symbol or risk phrase is required according to EEC labelling regulations.

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed
Dose descriptor:: LD50
Value:: 2 000 mg/kg bw
Quality of whole database:: K1

Additional information

Acute toxicity: oral

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat.

There were no deaths. Blue-coloured urine was noted in all animals. All animals recovered two days after dosing. All animals showed expected gain in bodyweight during the study. All animals showed dark blue-coloured outer cortex of the kidneys at necropsy. The females also showed blue-coloured staining of the non-glandular epithelium of the stomach.

The acute oral median lethal dose (LD50) of the test material in the Sprague -Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.

Acute toxicity: dermal

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat.

There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight.

Justification for classification or non-classification

Acute toxicity: oral

Acute toxicity: dermal

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