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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 January 2012 to 09 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female; The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 – 9 weeks, females: 11 – 12 weeks
Body weight on the day of administration: males: 232 – 254 g; females: 216 – 219 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the
German Act on Animal Welfare the animals were bred for experimental purposes.
ENVIROMENTAL CONDITION
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological
controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- Diprom, lot no. 10952-1, expiry date: 09/2013
- Details on dermal exposure:
- The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing
and non-irritating tape and was fixed with an additional dressing in a suitable manner. - Duration of exposure:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was
removed using tap water. - Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- Observation period:
All animals were observed for 14 days after dosing
Weight Assessment:
The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
Clinical Examination:
careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention
given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for
clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally
(Narcoren®, Merial) at the dosage of approximately 8 mL/kg bw. All animals were subjected to gross necropsy. All gross pathological changes
were recorded and in case of findings the tissues were preserved for a possible histopathological evaluation. The preserved tissues of which
no histopathological evaluation was made will be discarded 3 months after the release of the final report unless otherwise agreed upon with
the sponsor.
Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described.
On the basis of the test results, the test item may be classified in one of the following classes in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC:
• Very toxic
Substances and preparations shall be classified as very toxic, and assigned the symbol “T+” and indication of danger “very toxic” in accordance with the criteria specified below:
R27 Very toxic in contact with skin
- LD50 dermal, rat or rabbit: <= 50 mg/kg
• Toxic
Substances and preparations shall be classified as toxic, and assigned the symbol “T” and indication of danger “toxic” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R24 Toxic in contact with skin
- LD50 dermal, rat or rabbit: 50 < LD50 <= 400 mg/kg
• Harmful
Substances and preparations shall be classified as harmful, and assigned the symbol “Xn” and indication of danger “harmful” in accordance with the criteria specified below. Risk phrases shall be assigned in accordance with the following criteria:
R21 Harmful in contact with skin
- LD50 dermal, rat or rabbit: 400 < LD50 <= 2000 mg/kg
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008:
Category 1: LD50 <= 50 mg/kg. DANGER. Skull and crossbones in diamond. Fatal in contact with skin.
Category 2: LD50 > 50 mg/kg <= 200 mg/kg. DANGER. Skull and crossbones in diamond. Fatal in contact with skin.
Category 3: LD50 > 200 mg/kg <= 1000 mg/kg. DANGER. Skull and crossbones in diamond. Toxic in contact with skin.
Category 4: LD50 > 1000 mg/kg <= 2000 mg/kg. WARNING. Exclamation point in diamond. Harmful in contact with skin.
On the basis of the test results, the following risk phrases may be assigned in conformity with the criteria given in GHS - Globally Harmonized System of Classification and Labelling of Chemicals, third revised edition, July 2009:
Category 1: LD50 <= 50 mg/kg. DANGER. Skull and crossbones in diamond. Fatal in contact with skin.
Category 2: LD50 > 50 mg/kg <= 200 mg/kg. DANGER. Skull and crossbones in diamond. Fatal in contact with skin.
Category 3: LD50 > 200 mg/kg <= 1000 mg/kg. DANGER. Skull and crossbones in diamond. Toxic in contact with skin.
Category 4: LD50 > 1000 mg/kg <= 2000 mg/kg. WARNING. Exclamation point in diamond. Harmful in contact with skin.
Category 5: LD50 > 2000 mg/kg <= 5000 mg/kg. WARNING. No symbol. May be harmful in contact with skin. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation
of the results is not regarded as necessary.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection and nasal discharge. These signs are considered to be common symptoms in acute dermal tests.
- Gross pathology:
- No treatment-related effects were observed.
- Other findings:
- No erythema or oedema was observed. Eschar was observed in 1 of 5 male and 1 of 5 female animals.
All signs of irritation were reversible within the observation period.
Any other information on results incl. tables
Table Clinical Signs of Systemic Toxicity – Individual Data - Males:
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 5) |
21/ male / |
0 min, 30 min |
no signs of toxicity |
1 h |
nasal discharge |
|
2 h until the end of the observation period |
no signs of toxicity |
|
22/ male / |
0 min, 30 min |
no signs of toxicity |
1 h |
nasal discharge |
|
2 h until the end of the observation period |
no signs of toxicity |
|
23/ male / |
during the whole observation period |
no signs of toxicity |
24/ male / |
during the whole observation period |
no signs of toxicity |
25/ male / |
during the whole observation period |
no signs of toxicity |
Table Clinical Signs of Systemic Toxicity – Individual Data – Females:
Animal |
Time of |
Observations (for Signs of Dermal Irritation, see Table 6) |
26/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
27/ female / 2000 mg/kg bw |
day 1 |
no signs of toxicity |
day 2 |
slightly reduced spontaneous activity, |
|
day 3 until the end of the observation period |
no signs of toxicity |
|
28/ female / 2000 mg/kg bw |
day 1 |
no signs of toxicity |
day 2 |
slightly reduced spontaneous activity |
|
day 3 until the end of the observation period |
no signs of toxicity |
|
29/ female / 2000 mg/kg bw |
0 min, 30 min |
no signs of toxicity |
1 h |
nasal discharge |
|
2 h until the end of the observation period |
no signs of toxicity |
|
30/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
min = minute(s), h = hour(s), bw = body weight;day1 = day of administration
Table Skin Irritation – Individual Data – Males:
Day after Start of Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 3 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 4 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 5 |
0/0 |
* |
0/0 |
es,* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 6 |
0/0 |
* |
0/0 |
es,* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 7 |
0/0 |
* |
0/0 |
es,* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 8 |
0/0 |
* |
0/0 |
es,* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 9 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 10 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 11 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 12 |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
nsf |
day 13 |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
nsf |
day 14 |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
nsf |
day 15 |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
nsf |
0/0 |
nsf |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) es = eschar; nsf = no specific findings; * = red coloured residue of the test item
|
Table Skin Irritation – Individual Data – Females:
Day after Start of Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 3 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 4 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 5 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 6 |
0/0 |
* |
0/0 |
* |
0/0 |
es, * |
0/0 |
* |
0/0 |
* |
day 7 |
0/0 |
* |
0/0 |
* |
0/0 |
es, * |
0/0 |
* |
0/0 |
* |
day 8 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 9 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 10 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 11 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 12 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 13 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 14 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 15 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
Comments: E = erythema; O = oedema; 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) es = eschar; nsf = no specific findings; * = red coloured residue of the test item
|
Table Absolute Body Weights in g and Body Weight Gain in %:
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g |
g |
g |
% |
21 / male |
238 |
246 |
276 |
16 |
22 / male |
244 |
249 |
277 |
14 |
23 / male |
254 |
266 |
298 |
17 |
24 / male |
248 |
251 |
290 |
17 |
25 / male |
232 |
240 |
265 |
14 |
26 / female |
216 |
213 |
220 |
2 |
27 / female |
216 |
214 |
226 |
5 |
28 / female |
217 |
209 |
218 |
0 |
29 / female |
219 |
209 |
214 |
-2 |
30 / female |
219 |
207 |
214 |
-2 |
Table Macroscopic Findings - Individual Data – Males and Females:
Dose: 2000 mg/kg bw |
||
Animal No. / |
Organ |
Macroscopic Findings |
21 / male |
- |
nsf |
22 / male |
- |
nsf |
23 / male |
- |
nsf |
24 / male |
- |
nsf |
25 / male |
- |
nsf |
26 / female |
- |
nsf |
27 / female |
- |
nsf |
28 / female |
- |
nsf |
29 / female |
- |
nsf |
30 / female |
- |
nsf |
Table LD50:
Dose (Unit)
|
Number of Animals Investigated |
Number of Intercurrent Deaths |
LD50 |
2000 mg/kg bw |
5 males |
0 |
> 2000 mg/kg bw |
2000mg/kg bw |
5 females |
0 |
> 2000 mg/kg bw |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item FAT 40858/A TE to rats at a dose
of 2000 mg/kg body weight was associated with no mortality but signs of toxicity (which are considered to be common symptoms
in acute dermal tests) and signs of irritation. The dermal LD50 was determined to be > 2000 mg FAT 40858/A TE / kg body weight.
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item FAT 40858/A TE has no obligatory
labelling requirement for percutaneous toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item FAT 40858/A TE has no obligatory labelling requirement for
percutaneous toxicity and is unclassified.
According to GHS (Globally Harmonized Classification System) the test item FAT 40858/A TE has no obligatory labelling requirement
for percutaneous toxicity and is classified into Category 5. - Executive summary:
On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC, the substance should be:
classified asvery toxic
classified astoxic
classified as harmful
not classified
X
limit test
X
On the basis of the test results given below and in conformity with the criteria given inAnnex I of Regulation (EC) 1272/2008, the substance should be:
classified into category 1
classified into category 2
classifiedinto category 3
classifiedinto category 4
not classified
X
On the basis of the test results given below and in conformity with the criteria given inGHS (Globally Harmonized System of Classification and Labelling of Chemicals), the substance should be:
classified into category 1
classified into category 2
classifiedinto category 3
classifiedinto category 4
classifiedinto category 5
X
not classified
LD50: > 2000 mg /kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): aqua ad injectionem
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, Method B.3, OPPTS 870.1200
Table: Results per Step
Sex
Dose
(mg/kg bw)Number
of AnimalsNumber
of Intercurrent Deathsmale
2000
5
0
female
2000
5
0
Signs of toxicity related to dose level used, time of onset and duration:
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection and nasal discharge. These signs are considered to be common symptoms in acute dermal tests.
Effect on organs (related to dose level): No treatment-related effects were observed.
Signs of irritation: No erythema or oedema was observed. Eschar was observed in 1 of 5 male and 1 of 5 female animals.
All signs of irritation were reversible within the observation period.
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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