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EC number: 700-932-4
CAS number: -
LD50 oral > 2000 mg/kg bwLD50 dermal > 2000 mg/kg bw
MORTALITY / CLINICAL SIGNS
Key: √ noted
* Examinations were performed
approximately 0.5, 1, 2, 3 and 5 hours after treatment.
No clinical signs were evident in any
animal during the acclimatization period.
Body weights are presented in grams.
Two groups, each of three female
HanRcc:WIST (SPF) rats, were treated with the test item by oral gavage
administration at a dosage of 2000 mg/kg body weight. The test item was
diluted in vehicle (purified water) at a concentration of 0.2 g/ml and
administered at a volume dosage of 10 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 30 minutes, 1, 2, 3 and 5 hours after treatment
on day 1 and once daily during test days 2-15. Mortality/viability was
recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after
administration on test day 1 (with the clinical signs) and twice daily
during days 2-15. Body weights were recorded on day 1 (prior to
administration) and on days 8 and 15. All animals were necropsied and
examined macroscopically. All animals survived until the end of the
study period. No clinical signs were observed during the course of the
study. The body weight of the animals was within the range commonly
recorded for this strain and age. No macroscopic findings were recorded
LD50 (female rat): greater than 2000 mg/kg
Five male and five female HanRcc:WIST
(SPF) rats were treated with the test item 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 dosage of 4 ml/kg. The
period was 24 hours.
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 30
minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily
during test days 2-15. Local signs were noted once daily from test day 2
to 15. Mortality/viability was recorded at approximately 30 minutes, 1,
2, 3 and 5 hours after administration on test day 1 (with the clinical
signs) and twice daily during days 2-15. Body weights were recorded on day1
(prior to administration) and on days8 and 15. All animals were
necropsied and examined macroscopically.
No deaths occurred during the study.
No clinical signs were observed during the
course of the study.
The body weight of the animals was within
the range commonly recorded for this strain and age.
No macroscopic findings were observed at
The median lethal dose of the test item
after single dermal administration to rats of both sexes, observed over
a period of 14 days is:
LD50 (rat): greater than 2000 mglkg body
There are no experimental data available
on the Leucophor 1111X, thus a read across approach with the structural
analogous substances has been proposed.
All the substances used in a read
across approach are Stilbene derivatives Fluorescent Whitening Agents
salts. They display similar structural and physicochemical properties;
all of them exhibit high degree of dissociation in water and very low
octanol/water partition coefficients because to a higher affinity with
water phase than the octanol one. The water solubility is due to the
sulphonated groups in the molecules. The differences occurring in the
structure formulas (i.e. substituents) are expected to not significantly
impact the toxicological characterisation.
Further details about the justification for read across approach
are given in the report attached to the Section 13 of this dossier.
ACUTE TOXICITY - ORAL ROUTE
In all the cases investigated, the
substances are clearly not harmful/toxic by oral route in rats up to
2000 and 5000 mg/kg bw. No signs of systemic toxicity were noted during
the studies and no abnormalities were noted. Only in one study one male
was killed one hour after dosing having sustained a broken leg. This was
done for humane reasons in accordance; the death was therefore not
attributed to the toxicity of the test material (Tomlinson, 1993).
ACUTE TOXICITY - INHALATION ROUTE
According to the REACH Regulation Annex
VIII Column 2 (specific rules for adaptation from column 1) in addition
to the oral route (8.5.1), for substances other than gases, the
information mentioned under 8.5.2 to 8.5.3 shall be provided for at
least one other route. The choice for the second route will depend on
the nature of the substance and the likely route of human exposure.
Because of the physical state and the trade forms of the substance
inhalation is not an appropriate route of exposure. The substance is
manufactured and used as aqueous solution, furthermore at manufacturing
level, the substance is handled with suitable risk management measures
and with the suitable personal protective equipments.
ACUTE TOXICITY - DERMAL ROUTE
No signs of systemic toxicity were noted
during the studies performed on analogous substances. The LD50 values
resulted to be greater than 2000 mg/kg bw in all the cases.
Slightly depressed bodyweight gains were
observed during the first week of treatment in the study performed on
analogous substance 02. The test was performed administering a dose of
5000 mg/kg bw. The bodyweight gain returned to normal during the second
week, compared with controls (Kynoch and Lloyd, 1975).
According to the CLP Regulation (EC
1272/2008), 3.1 Acute toxicity section, substances can be allocated to
one of four toxicity categories based on acute toxicity by the oral,
dermal or inhalation route according to the numeric criteria. Acute
toxicity values are expressed as (approximate) LD50 (oral, dermal) or
LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be
greater than 2000 mg/kg body weight, therefore the test substance is out
of any classification limit for acute oral toxicity (oral acute toxicity
category 4: 300 < ATE ≤ 2000 mg/kg bw).
The dermal LD50 value was established to
exceed 2000 mg/kg body weight, which exceeded the highest CLP
classification limit (dermal acute toxicity category 4: 1000 < ATE ≤
2000 mg/kg bw).
In conclusion, the test substance is not
classified for oral and dermal acute toxicity, according to the CLP
Regulation (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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