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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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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
- 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Between 6 October 1999 and 14 October 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to guidelines and GLP and reported fully.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- 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:
- other: Japanese Agricultural Chemicals Laws & Regulations Testing Guidelines for Toxicology Studies (MAFF) [59 NohSan No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- EC Number:
- 274-263-7
- EC Name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- Cas Number:
- 70024-69-0
- IUPAC Name:
- sodium 4-icosylbenzenesulfonate
- Test material form:
- other: liquid
- Details on test material:
- the test substance was a similar material to the registered substance (aryl alkyl sulphonate)
- Storage condition of test material: Ambient
- Other: Dark brown viscous liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2071 to 2480 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): LabDiet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (68.3 - 68.8 °F)
- Humidity (%): 30.2-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24h, 48h, 72h and 8 days
- Number of animals:
- 3/sex
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with paper towels moistened with deionised water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Mean score calculated by average of results at 24h, 48h and 72h for each animal.
Any other information on results incl. tables
Table 1: 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 |
Oedema |
Max. score: 2 |
Max. score: 1 |
|
24 h |
1/1/1/2/1/1 |
1/0/1/0/1/0 |
48 h |
1/1/1/2/1/1 |
1/0/0/0/0/0 |
72h |
1/1/1/1/1/1 |
1/0/0/0/0/0 |
Average 24h, 48h, 72h |
1.2/1.2/1 |
0.5/0.2/0.2 |
Reversibility*) |
c |
c |
Average time (unit) for reversion |
7 days |
48h |
*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible
Mortality: There were no deaths during the study.
Dermal Observations (Table 2):
Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided
by day 8.
The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The test article received a descriptive rating classification of slightly irritating.
TABLE 2 |
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PROJECT NO.WIL-168169 |
ACUTE DERMAL IRRITATION STUDY IN ALBINO RABBITS |
||||||||||||||||||||
SITE A: 0.5 ML/SITE |
|||||||||||||||||||||
|
ERYTHEMA |
EDEMA |
|||||||||||||||||||
ANIMAL |
SEX |
SITE |
1H |
24H |
48H |
72H |
4D |
5D |
6D |
7D |
8D |
SITE |
1H |
24H |
48H |
72H |
4D |
5D |
60 |
7D |
8D |
29982 |
M |
A |
1s |
1s |
1 |
1 |
1 |
1 |
0d |
- |
- |
A |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
- |
- |
29983 |
M |
A |
0s |
1s |
1 |
1 |
1 |
1 |
0d |
- |
- |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
29984 |
M |
A |
0s |
1s |
1 |
1d |
1d |
1d |
1d |
1d |
0 |
A |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
29993 |
F |
A |
1 |
2 |
2 |
1d |
1d |
1d |
1d |
0d |
- |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
29994 |
F |
A |
1 |
1 |
1 |
1d |
1d |
0d |
- |
- |
- |
A |
1 |
1 |
0 |
0 |
0 |
0 |
- |
- |
- |
29995 |
F |
A |
1 |
1 |
1 |
1 |
1 |
1d |
0d |
- |
- |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
|
|
TOTAL |
4 |
7 |
7 |
6 |
6 |
5 |
2 |
1 |
0 |
TOTAL |
1 |
3 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
PII calculated using test periods: 24h, 48h, 72 h |
|||||||||||||||||||||
Primary Irritaton Index (PII) = [(7+7+6)/18] + [(3+1+1)/18] |
|||||||||||||||||||||
(PII) = [20/18] + [5/18] |
|||||||||||||||||||||
(PII) = 1.1 + 0.3 |
|||||||||||||||||||||
PII = 1.4 = SLIGHTLY IRRITATING |
|||||||||||||||||||||
PII calculated using test periods: 24h, 72 h |
|||||||||||||||||||||
Primary Irritaton Index (PII) = [(7+6)/12] + [(3+1)/12] |
|||||||||||||||||||||
(PII) = [13/12] + [4/12] |
|||||||||||||||||||||
(PII) = 1.1 + 0.3 |
|||||||||||||||||||||
PII = 1.4 = SLIGHTLY IRRITATING |
|||||||||||||||||||||
|
|||||||||||||||||||||
H = HOURS |
|||||||||||||||||||||
D = DAYS |
|||||||||||||||||||||
F = FEMALE |
|||||||||||||||||||||
M = MALE |
|||||||||||||||||||||
d = DESQUAMATION |
|||||||||||||||||||||
s = DOSE SITE STAINED YELLOW |
|||||||||||||||||||||
- = DERMAL IRRITATION PREVIOUSLY SUBSIDED; ANIMAL TERMINED FROM STUDY |
Body Weights (Table 3):
There were no remarkable body weight changes during the study.
Table 3 |
||||||
Acute Dermal Irritation Study in Albino Rabbits |
||||||
Individual Body Weights (Grams) |
||||||
Initiation |
Termination |
|||||
Group |
Number |
Sex |
(Day 0) |
(Interval) |
||
0.5 ml/site |
29982 |
M |
2480 |
2693 (Day 6) |
||
29983 |
M |
2218 |
2320 (Day 6) |
|||
29984 |
M |
2329 |
2504 (Day 8) |
|||
29993 |
F |
2071 |
2294 (Day 7) |
|||
29994 |
F |
2213 |
2507 (Day 5) |
|||
29995 |
F |
2311 |
2596 (Day 6) |
|||
M = Male |
||||||
F = Female |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- Mean scores for each animal at 24h, 48h and 72 h for erythema and oedema, respectively, were 0. Therefore, this substance is not irritating to skin under the conditions of this test.
- Executive summary:
The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. There was one group of six young adult albino rabbits that received a single, four-hour, semioccluded exposure. Each 0.5 ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes and 24,48 and 72 hours after patch removal and daily through day 8, if irritation persisted. Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided by day 8. The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The calcium sulfonate read across substance (CAS 70024 -69 -0) received a descriptive rating classification of slightly irritating. The Primary Irritation Index (PII) was 1.4 (24, 48 and 72 hours) and 1.4 (24 and 72 hours). This is however, not considered to be irritating taking into account the classification criteria for skin irritation by the european global harmonised system (a dermal irritant is a substance which causes a primary irritation index of >2.3 < 4).
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