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EC number: 224-506-8 | CAS number: 4390-04-9
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- Appearance / physical state / colour
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- 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

Endpoint summary
Administrative data
Description of key information
All reliable studies on skin and eye irritation for C14-20 Aliphatics (≤2% aromatic) show no or slight irritation effects on rabbit skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1998/09/14 to 1998/09/25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD guideline N°404 in compliance with GLP. Substance analytical certificate not available
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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)
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Russian from Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: no data
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): A pelleted complete rabbit "Altromin 2123" diet ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12h
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Electric clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reaction assessed at 1, 24, 48 and 72 hours and 7 days after exposure (after the removal of the patch)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 2.5 cm X 2.5 cm (left+ right)
- % coverage: no data
- Type of wrap if used: Nobifix (6 cm width) was loosely wound round the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was cleaned with lukewarm water and mild soap
- Time after start of exposure: 4 hours
SCORING SYSTEM: in accordance with the OECD guideline 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See Table I, the test substance is slightly irritating:
- The mean individual erythema scores were 0.2, 0.3 and 0.5 respectively
- The mean individual oedema scores were 0.7, 0.0 and 0.0 respectively - Other effects:
- none
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, DEV 98-25 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
- Executive summary:
In a primary dermal irritation study conducted according to OECD guideline N°404, three rabbits were exposed to 0.5 mL of DEV 98-25 at two skin sites on the back.
Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 7 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.
The mean individual scores were 0.2, 0.3 and 0.5 for erythema and 0.7, 0.0 and 0.0 for edema.
Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, DEV 98 -25 is not considered as irritating to the rabbit skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Table I: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
24 h |
L: 1/1/1 R: 0/1/1 |
L and R: 0/0/0 |
48 h |
L: 0/0/0 R: 0/0/1 |
L: 1/0/0 R: 1/0/0 |
72 h |
L: 0/0/0 R: 0/0/0 |
L: 1/0/0 R: 1/0/0 |
Average 24h, 48h, 72h |
L+R: 0.2 -0.3- 0.5 |
L and R: 0.7-0-0 |
Reversibility* |
C |
C |
Average time (unit) for reversion |
within 72 hours |
within 7 days |
L: left test flank R: right test flank C: completely reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 September 1998 to 02 October 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline N°405, GLP but substance analytical certificate not available (Substance identification: code name with information on test substance).
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation was not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age of animals at study initiation was not reported
- Principles of method if other than guideline:
- Guideline study
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: M & B, Ejby, DK-4623 Lille Skensved, Denmark
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: kept individually in PPO/HIPS cages (Noryl, floor area = 2576 cm²)
- Diet: pelleted complete rabbit diet "Altromin 2123" from Ch. Petersen ad libitum. Analysis for major nutritive components and relevant possible contaminations in the diet are performed regularly.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 ad libitum. Analyses for relevant possible contamination in the water are performed regularly.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): 10
- Photoperiod :12 hrs dark /12 hrs light
IN-LIFE DATES: From: To: - Vehicle:
- not specified
- Controls:
- other: the right eye of the treated animals was used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours after application
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 20 mL 0.9% sodium chloride solution
- Time after start of exposure: 24 hrs
SCORING SYSTEM: grading according to OECD 405 recommendation
TOOL USED TO ASSESS SCORE: fluorescein, UV light - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean individual score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- iris score
- Basis:
- other: mean individual score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- chemosis score
- Basis:
- other: mean individual score for all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #3 - Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See Table 1 for details
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- other: See Table 1 for details
- Irritant / corrosive response data:
- Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals and were fully reversed at 72h in all animals. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that DV 98-25 would not be classified as eye irritant. - Other effects:
- No data
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- under the test conditions, DV 98-25 is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
- Executive summary:
The eye irritant effect of DV 98-25 was investigated according to the OECD Guideline No. 405 (1987) and EEC B.5 method (1992) and in compliance with Good Laboratory Practice.
Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours after dosing.
Minimal conjunctival irritation (redness) was observed in the three rabbits 1 hour after dosing. During the rest of the observation period no abnormalities were observed for two animals while redness (score 1) was still observed up to 48 h in the third animal.
DV 98 -25 is not considered as irritating to the eyes according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
Table 1: DV 98 -25 Acute eye irritation/corrosion study in the rabbit. Scores for ocular lesions.
Rabbit No / |
1 h |
24 hrs |
|
48 hrs |
72 hrs |
Individual mean score* |
||
weight (kg) |
F |
|||||||
3531 / 2.3 |
Cornea opacity, area |
0 |
0 |
0 |
0 |
0 |
|
|
Cornea opacity, degree |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
|
0 |
0 |
0.0 |
||
Conjunctiva |
Chemosis |
0 |
0 |
|
0 |
0 |
0.0 |
|
Redness |
1 |
0 |
|
0 |
0 |
0.0 |
||
Discharge |
3 |
0 |
|
0 |
0 |
|||
|
||||||||
3533 / 2.3 |
Cornea opacity, area |
0 |
0 |
0 |
0 |
0 |
|
|
Cornea opacity, degree |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
|
0 |
0 |
0.0 |
||
Conjunctiva |
Chemosis |
0 |
0 |
|
0 |
0 |
0.0 |
|
Redness |
1 |
1 |
|
1 |
0 |
0.7 |
||
Discharge |
3 |
0 |
|
0 |
0 |
|||
|
||||||||
3534 / 2.8 |
Cornea opacity, area |
0 |
0 |
0 |
0 |
0 |
|
|
Cornea opacity, degree |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
|
0 |
0 |
0.0 |
||
Conjunctiva |
Chemosis |
0 |
0 |
|
0 |
0 |
0.0 |
|
Redness |
1 |
0 |
|
0 |
0 |
0.0 |
||
Discharge |
3 |
0 |
|
0 |
0 |
0.0 |
F: Reading after instillation of oculoguttae fluoresceini.
* Only the scores from the 3 readings (24, 48 and 72 hours) are included in the calculation of the individual mean scores
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Fourteen reliable studies were available for skin irritation, dealing with the toxicity of different samples of C14-20 Aliphatics (≤2% aromatic). All studies were conducted similarly or according to OECD guideline 404. All studies show no or slight irritation effects on rabbits' skin. One reliable study was performed with human volunteers exposed to isohexadecane and isoeicosane for 24 h in occlusive conditions. Only slight signs of irritation lead to the conclusion that test substances were not skin irritant.
Nine studies were available for eye irritation, dealing with the toxicity of different samples of C14-20 Aliphatics (≤2% aromatic). All studies were conducted similarly or according to OECD guideline 405. All studies show no or slight irritation effects on rabbits' eyes.
Justification for classification or non-classification
As all reliable studies show no irritation effect or irritation effects slight enough not to classify the test materials, substances of the category do not need to be classified as irritant for skin and eye according to the criteria of Annex VI of Directive 67/548/EEC and CLP Regulation 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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