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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 27, 2002 - May 14, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
July 31, 1992
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
444-050-5
EC Name:
-
IUPAC Name:
dodecasodium 5-({4-chloro-6-[ethyl({3-[2-(sulfooxy)ethanesulfonyl]phenyl})amino]-1,3,5-triazin-2-yl}amino)-3-[(E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate 5-({4-chloro-6-[ethyl({3-[2-(sulfooxy)ethanesulfonyl]phenyl})amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 5-[(4-chloro-6-{[3-(ethenesulfonyl)phenyl](ethyl)amino}-1,3,5-triazin-2-yl)amino]-3-[(E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate 5-[(4-chloro-6-{[3-(ethenesulfonyl)phenyl](ethyl)amino}-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate
Test material form:
solid
Details on test material:
Identity: Red Rwa 4565
Appearance: Solid, red powder
Storage: at room temperature at about 20°C

Test animals

Species:
rat
Strain:
other: HanBrl: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Females (if applicable) nulliparous and non-pregnant: no
- Age when treated: 8 weeks (males), 10 weeks (females)
- Weight when treated: males 247.6-263.9 g, females 168.5-188.3 g
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. lndividually in Makrolon type-S cages with standard softwood bedding ("Lignocel", Schill AG, CH- 4132 Muttenz) during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 119/01 (Provimi Kliba AG, CH-4303 KaiseraugsV Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
deionised water which was processed and treated by the PURELAB Option-R unit.
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24h after the application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.5 g test item /mL vehicle
- Constant volume or concentration used: yes

VEHICLE : purified water
- Amount(s) applied (volume or weight with unit): 4mL (vehicle + test item)/kg
- Concentration (if solution): 0.5 g test item /mL vehicle
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Mortality/viability: Daily during acclimatization and twice daily during days 1-15.

- Necropsy of survivors performed: yes
At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically. Thereafter, they were discarded.

- Other examinations performed: clinical signs, body weights

Body weights: On test days 1 (prior to administration), 8 and 15.
Clinical signs: Daily during acclimatization and at approximalely 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded.
Statistics:
No statistical analysis was performed.

Results and discussion

Preliminary study:
Not performed
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No deaths occurred during the study.
Clinical signs:
No systemic signs of toxicity were obserued during the study period.
Violet discoloration of the treated skin area produced by the test item was noted in all animals after removal of the dressing and persisted until the end of the observation period.
Test item residue was additionally noted until test day 8.
Body weight:
One female animal showed a loss of body weight (1.9 %) between treatment start and test day 8. lt recovered at the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose of Red RWa 4565 after single dermal administration to rats of both sexes, observed over a period of 14 days, is > 2000 mg/kg bw in test performed according to OECD TG 402 and following GLP.
Executive summary:

The acute dermal toxicity of Red RWa 4565 has been determined in the current study performed following OECD TG 402 according to GLP.

A group of five male and five female HanBrl: WIST (SPF) rats was treated with Red RWa 4565 at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.5 g/ml and administered at a volume of 4 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15.

Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days I and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

No clinical signs were observed during the observation period.

Violet discoloration of the treated skin area produced by the test item was noted in all animals after removal of the dressing and persisted until the end of the observation period.

Test item residue was additionally noted until test day 8.

One female animal showed a loss of body weight (1.9 %) between treatment start and test day 8. lt recovered at the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

 

The median lethal dose of Red RWa 4565 after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): > 2000 mg/kg bw