Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-02-13 to 2012-03-29
- 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Housing and Feeding Conditions:
- Semi barrier in an air-conditioned room
- Temperature: 18 +/- 3 °C (recommendations of TVT, GV-SOLAS)
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1610), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- Aqua ad injectionem, Diprom, lot no. 109521-1, expiry date 09/2013
- Controls:
- no
- Amount / concentration applied:
- A dose of 0.5 g of the test item was applied to each test site.
- Duration of treatment / exposure:
- The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with tap water. - Observation period:
- All animals were observed for 72 hours after the patch removal.
- Number of animals:
- 3
- Details on study design:
- Clinical Observation:
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal. Dermal irritation was scored and recorded according to the grades in the table below. Any other signs such as hyperplasia, scaling, discolouration, fissures and scabs or any systemic effects were also recorded.
For the initial test in one animal, the test site was also examined immediately after the patch had been removed.
Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Nature, severity and duration of all lesions observed were described.
The body weight development was recorded at the start and at the end of the study.
On the basis of the test results, the test substance may be classified in one of the following classes in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC:
Corrosive and assigned the symbol „C“ and the indication of danger corrosive in accordance with the following criteria:
- a substance or a preparation is considered to be corrosive if, when it is applied to healthy intact animal skin, it produces full thickness destruction of skin tissue on at least one animal during the test for skin irritation cited in Annex B.4 to Commission Regulation (EC) No. 440/2008, L 142 or during an equivalent method,
- classification can be based on the results of a validated in vitro test, such as that cited in Annex B.40 to Commission Regulation (EC) No. 440/2008, L 142 (skin corrosion: rat skin transcutaneous electrical resistance assay and human skin model assay),
- a substance or a preparation should also be considered corrosive if the result can be predicted, for example from strongly acid or alkaline reactions indicated by a pH of 2 or less or 11.5 or greater. However, where extreme pH is the basis for classification, acid/alkali reserve may also be taken into consideration. If consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive then further testing should be carried out to confirm this, preferably by use of an appropriate validated in vitro test. Consideration of acid/alkali reserve should not be used alone to exonerate substances or preparations from classification as corrosive.
Risk phrases shall be assigned in accordance with the following criteria:
R35 Causes severe burns
- if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to three minutes exposure, or if this result can be predicted.
R34 Causes burns
- if, when applied to healthy intact animal skin, full thickness destruction of skin tissue occurs as a result of up to four hours exposure, or if this result can be predicted,
- organic hydroperoxides, except where evidence to the contrary is available.
Notes:
Where classification is based on results of a validated in vitro test R35 or R34 should be applied according to the capacity of the test method to discriminate between these.
Where classification is based upon consideration of extreme pH alone, R35 should be applied.
Irritant and assigned the symbol „Xi“ and the indication of danger „irritant“ in accordance with the criteria given below.
The following risk phrase shall be assigned in accordance with the criteria given:
R38 Irritating to skin
- Substances and preparations which cause significant inflammation of the skin which persists for at least 24 hours after an exposure period of up to four hours determined on the rabbit according to the cutaneous irritation test method cited in Annex B.4 to Commission Regulation (EC) No. 440/2008, L 142 (skin corrosion).
Inflammation of the skin is significant if:
(a) the mean value of the scores for either erythema and eschar formation or oedema formation, calculated over all the animals tested, is 2 or more; or
(b) in the case where the Annex B.4 (skin corrosion) test has been completed using three animals, either erythema and eschar formation or oedema formation equivalent to a mean value of 2 or more calculated for each animal separately has been observed in two or more animals.
In both cases all scores at each of the reading times (24, 48 and 72 hours) for an effect should be used in calculating respective mean values.
Inflammation of the skin is also significant if it persists in at least two animals at the end of the time of observation. Particular effects e.g. hyperplasia, scaling, discoloration, fissures, scabs and alopecia should be taken into account. Relevant data may also be available from non-acute animal. These are considered significant if the effects seen are comparable to those described above.
- Substances and preparations which cause significant inflammation of the skin, based on practical observations in humans on immediate, prolonged or repeated contact.
- Organic peroxides, except where evidence to the contrary is available.
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:
Skin corrosion, category 1 A, B, C:
Destruction of skin tissue, with subcategorisation based on exposure of up to 3 minutes (A), 1 hour (B), or 4hours (C). DANGER, corrosion symbol in diamond. Causes severe skin burns and eye damage.
Skin irritation, category 2:
Mean value of >=2.3 <= 4.0 for erythema / eschar or edema in at least 2 of 3 tested animals from gradings at 24, 48, and 72hours (or on 3 consecutive days after onset if reactions are delayed); inflammation that persists to the end of the (normally 14-day) observation period in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above. WARNING, exclamation mark in diamond. Causes skin irritation.
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:
Skin corrosion, category 1 A, B, C: Destruction of skin tissue, with subcategorisation based on exposure of up to 3 minutes (A), 1 hour (B), or 4 hours (C). DANGER, corrosion symbol in diamond. Causes severe skin burns and eye damage.
Skin irritation, category 2: Mean value of >= 2.3 > 4.0 for erythema / eschar or oedema in at least 2 of 3 tested animals from gradings at 24, 48, and 72hours (or on 3 consecutive days after onset if reactions are delayed); inflammation that persists to end of the (normally 14-day) observation period. WARNING, exclamation mark in diamond. Causes skin irritation.
Skin irritation, category 3: Mean value of >= 1.5 < 2.3 for erythema / eschar or oedema in at least 2 of 3 tested animals from gradings at 24, 48, and 72 hours (or on 3 consecutive days after onset if reactions are delayed). WARNING, no symbol. Causes mild skin irritation.
No classification or labelling unless category 1 – 3 criteria are met.
Results and discussion
In vivo
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed on the intact skin of the three female rabbits (strain NZW) after a contact time of 4 hours.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
There were no significant body weight changes during the contact and observation period.
Any other information on results incl. tables
Table: Dermal Irritation Evaluation
Animal |
Application |
Irritation (hours after patch removal) |
|||||||
1 hour |
24 hours |
48 hours |
72 hours |
||||||
T |
C |
T |
C |
T |
C |
T |
C |
||
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
T = test item; C = control
Table: Individual Data
Individual Systemic and Local Findings - Animal No. 1 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf. |
residue of the test item |
- |
24 hours |
nsf |
residue of the test item |
- |
48 hours |
nsf |
residue of the test item |
- |
72 hours |
nsf |
residue of the test item |
- |
Individual Systemic and Local Findings - Animal No. 2 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf |
residue of the test item |
- |
24 hours |
nsf |
residue of the test item |
- |
48 hours |
nsf |
residue of the test item |
- |
72 hours |
nsf |
residue of the test item |
- |
Individual Systemic and Local Findings - Animal No. 3 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf |
residue of the test item |
- |
24 hours |
nsf |
residue of the test item |
- |
48 hours |
nsf |
residue of the test item |
- |
72 hours |
nsf |
residue of the test item |
- |
nsf = no specific findings
Table: Absolute Body Weights in kg
|
Animal No. 1 |
Animal No. 2 |
Animal No. 3 |
Start of Study |
3.7 |
3.6 |
4.4 |
End of Study |
3.7 |
3.7 |
4.5 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the present study, the single dermal application of the test item FAT 40858/A TE to three rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item FAT 40858/A TE does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item FAT 40858/A TE does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item FAT 40858/A TE has no obligatory labelling requirement for skin irritation.
For details of the classification criteria, see Evaluation of Results. - 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[6], the substance should be assigned the following risk phrase:
R38 irritating to skin
R34 causes burns
R35 causes severe burns
no phrase
X
On the basis of the test results given below and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008, the substance should be:
classified into category 1
classified into category 2
not classified
X
On the basis of the test results given below and in conformity with the criteria given in GHS (Globally Harmonized System of Classification and Labelling of Chemicals), the substance should be:
classified into category 1
classified into category 2
classified into category 3
not classified
X
Species/strain: New Zealand White Rabbits Crl: KBL (NZW)
Number of animals: 3
Duration of exposure: 4 hours
Amount of substance: 0.5 g per test site
Type of dressing: occlusive [ ] semi-occlusive [ X ]
Vehicle (moistening): aqua ad injectionem
First time of effects: no effects observed
Last time of effects: no effects observed
Reversibility of the
observed effects: no effects observedMethod: OECD 404
EC 440/2008, Method B.4
OPPTS 870.2500
Average Scores – (24, 48, 72 hour reading)
Mean Value Irritation Scores
Animal No.
Mean 24 – 72 hours
Erythema
Oedema
1
0
0
2
0
0
3
0
0
Total Mean Value
0
0
Conclusion:
Under the conditions of the present study, the single dermal application of the test item FAT 40858/A TE to three rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item FAT 40858/A TE does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item FAT 40858/A TE does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item FAT 40858/A TE has no obligatory labelling requirement for skin irritation.
For details of the classification criteria, see Evaluation of Results.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Въпреки че ECHA предоставя много онлайн материали на Вашия език, част от страницата е налична само на английски език. Научете повече за многоезиковата практика на ECHA.
Добре дошли на уебсайта на ECHA. Уебсайтът не се поддържа напълно от Internet Explorer 7 (и по-стари версии). Обновете Internet Explorer с по-нова версия.
За да гарантираме, че се възползвате максимално от функциите на нашия уебсайт, сме въвели „бисквитки“.
FНаучете повече как използваме бисквитките.