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EC number: 203-973-1 | CAS number: 112-45-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin in rabbits
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Undec-10-enal
- EC Number:
- 203-973-1
- EC Name:
- Undec-10-enal
- Cas Number:
- 112-45-8
- Molecular formula:
- C11H20O
- IUPAC Name:
- undec-10-enal
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Undec-10-enal
- Molecular formula (if other than submission substance): C11H20O
- Molecular weight (if other than submission substance): 168.28 g/mol
- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 98.62%
- Lot/batch No.: KC/C11/1402070
- Expiration date of the lot/batch: July, 2014
- Storage condition of test material: Refrigerator (2 - 8 °C)
- Other:
Handling and Disposal
Safety precautions: Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal: The remaining unused test item was disposed as per internal SOPs of sa-FORD and the same was documented in the raw data.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Procured from LIVEON BIOLABS PVT. LTD., Karnataka, 572106, (CPCSEA Reg. No. 1610/RO/bc12/CPCSEA).
- Sex: Male
- Health Status: Healthy young adults rabbits were used for the study.
- Age at study initiation: 4.0 to 4.5 Months (Approximately)
- Weight at study initiation: Minimum: 1.888 kg and Maximum: 2.612
- Housing: The animals were housed individually in stainless steel cages
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No. 200004
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum
- Acclimation period: Rabbits were acclimatised to the test conditions for a period of 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item
- Identification : During acclimatization marking was done with non toxic marker pen in the inside of left ear of rabbits and after acclimatization, animals were marked with permanent number in the inner side of right ear of rabbits. Permanent marker and cage card was used for identification. The individual cage cards were labelled with at least study no., study type, test system, sex, dose, experiment start date and experiment completion date.
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed minimum twice a week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.90 °C and Maximum: 22.50 °C
- Humidity (%): Minimum: 51.50 % and Maximum: 67.40 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
VEHICLE: Not applicable - Duration of treatment / exposure:
- 4-hour exposure period
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 X 6 cm at contralateral sites
- Type of wrap if used: porous gauze dressing and non-irritating tape (Micropore 3”)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using cotton soaked in distilled water
- Time after start of exposure: 4hr
Control site: 0.5 ml distilled water was applied at control site.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: #2 and #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: at 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
Body weights were increased as compared to day 0 in all the three animals
Any other information on results incl. tables
Table 1: Skin Reaction
In Treated area Dose:0.5 ml of test item Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Right |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
0 |
2 |
Confirmatory |
Left |
1 |
2 |
2 |
2 |
0 |
1 |
1 |
2 |
1 |
0 |
3 |
Left |
1 |
2 |
2 |
2 |
0 |
1 |
1 |
2 |
2 |
0 |
In Control area Dose: 0.5 ml of distilled water Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key: h = Hour.
Erythema Oedema
0 =No erythema 0 =No oedema
1 =Very slight erythema (barely perceptible) 1 =Very slight oedema (barely perceptible)
2 =Well defined erythema 2 = Slight oedema (edges of area well defined by definite raising)
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
1.00 |
2.00 |
2.00 |
Oedema |
1.00 |
1.33 |
1.67 |
Table 2: Individual Animal Body Weight
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
1.888 |
2.048 |
2 |
2.184 |
2.210 |
3 |
2.612 |
2.648 |
Table 3: Individual AnimalClinical Signs
Animal No. |
Days (Post dosing Observation) |
|||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively.
Hence, it was concluded that the test chemical was Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested. - Executive summary:
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per the OECD guideline No. 404.Three healthy young adult male rabbits were used for conducting acute dermal irritation study. The hair of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A volume of 0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with cotton soaked in distilled water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.
At 1 hour observation animal no. 1 revealed no erythema and no oedema. At 24 hour observation very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 and 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible)at 1 hour observation. At 24 hour observation animal no. 2 and 3 revealed well defined erythema and very slight oedema (barely perceptible).At 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible) and animal no. 3revealedwell defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3recovered to normal on day 7. The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 1.00, 2.00, 2.00 and 1.00, 1.33, 1.67, for erythema and oedema formation, respectively. Hence, it was concluded that the test chemical is Mild Skin Irritant to the skin of Male New Zealand White rabbits under the experimental conditions tested.
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.
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