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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-07-22 to 1985-08-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
- Molecular formula:
- Na(C21-25H33-41O3)
- IUPAC Name:
- Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., sodium salts
- Details on test material:
- - Physical state: Dark brown liquid
- Stability under test conditions: Stable for the duration of the study
- Expiry date: Assigned as one calendar month from the date of issue (18 July 1985)
- Storage conditions of test material: In the dark at ambient temperature
- Date received: 08 July 1985
- Density/Specific gravity: 0.985 kg/L at 20 °C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age on receipt from supplier: 3-6 months
- Age at study initiation: 4-9 months
- Weight at study initiation: 4790-4862 g (female); 4008-4106 g (male)
- Housing: Singly housed in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cage measured 67 x 43 x 45 cm. The cages were mounted in three rows of two on a single-sided rack (a total of six cages).
- Diet: ad libitum by means of a top-loading food hopper
- Water: Filtered but untreated from water from the public supply by means of an automatic valve-regulated drinking line
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 °C
- Humidity (%): Monitored but values not stated
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): Light 06:00 to 18:00 GMT; Dark 18:00 to 06:00 GMT via fluorescent tubes
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
- Number of animals:
- Three males and three females
- Details on study design:
- A semi-occlusive patch test was used to assess the primary skin irritation induced by the undiluted test material. Each animal was identified by means of a number metal ear tag and/or a number written on the pinna.
Dorsal hair between the shoulders and hindquarters was closely shorn with fine electric clippers. A test site was selected and a 2 x 2 cm lint patch dosed with 0.5 mL of the test material applied to it. The patch and surrounding skin were covered by a single layer of gauze held in place by means of an elastic adhesive bandage.
After 4 hours the wrapping and patch were removed. The site was examined and scored for erythema and oedema on a graded scale of 0 to 4 using the criteria given in the applicable tables (attached). Observations were made at 30 minutes after removal of the patch (i.e. approximately 4 hours after application) and at 24, 48 and 72 hours plus 7, 14, and 21 days after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 804M
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 804M
- Time point:
- 48 h
- Score:
- 2.5
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 804M
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 800M
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 800M
- Time point:
- 48 h
- Score:
- 2.5
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 800M
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 805M
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 805M
- Time point:
- 48 h
- Score:
- 2.5
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 805M
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 833F
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 833F
- Time point:
- 48 h
- Score:
- 2.5
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 833F
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 801F
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 801F
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 801F
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 836F
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 836F
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 836F
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 804M
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 804M
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 804M
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 800M
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 800M
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 800M
- Time point:
- 72 h
- Score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 805M
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 805M
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 805M
- Time point:
- 72 h
- Score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 833F
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 833F
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 833F
- Time point:
- 72 h
- Score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 801F
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 801F
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal: 801F
- Time point:
- 72 h
- Score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 836F
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 836F
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 836F
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritant / corrosive response data:
- All rabbits had slight inflammation of the treated site by 24 hours post-dosing which progressively increased until, by 72 hours, five rabbits had necrosis; by 7 days all six rabbits were thus affected. By 14 days the treated skins were either lifting or had lifted to reveal slightly discoloured new skin with small, semi-raw areas in three animals (see Table 2, attached). There are additional time points included in the study which have not been included in the Results table above as this is an older study conducted out to 21 days. the maximum results were however obtained after around 72hrs and did not reverse so only timepoints to 72hrs are relevant. All data has been provided in the attachment for reference.
By 21 days the skin reaction had cleared completely in two rabbits but three animals still had a light brown discolouration of the skin; it was anticipated that this would clear in time. However, the skin of 805 M was discoloured (purple) and thickened, which was taken as a permanent alteration to the skin of this animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test material caused irreversible damage to the skin of one rabbit and is therefore considered to be corrosive.
- Executive summary:
The potential of the test material to cause skin irritation was assessed in a study conducted using methodology equivalent to that outlined in the standardised guideline OECD 404 under GLP conditions.
Three males and three female New Zealand White rabbits were exposed to the test material in a semi-occlusive fashion for 4 hours. A lint patch dosed with 0.5 mL of the undiluted test material was applied to the shaved skin of the rabbits. Following the exposure, rabbits were observed 30 minutes after removal of the patch (i.e. approximately 4 hours after application) and at 24, 48 and 72 hours plus 7, 14, and 21 days after application. The site was examined and scored for erythema and oedema on a graded scale of 0 to 4.
There was so little inflammation (erythema) half an hour after removal of the patch that a score between 0 and 1 was assigned for each animal. Although not a standard procedure, if the response was considered to be between the scores usually used (i.e., 0 to 4 for both erythema and oedema) an intermediate score was allocated. Inflammation progressed afterwards, reaching a maximal point on day 7 when all animals were assigned 4 for both erythema and oedema and a note was added in the report to state “All treated skins thickened with light brown, necrotic appearance so maximum scores given.“ At 14 days there was some recovery, but 3 out of the 6 rabbits still had erythema values > 2. At 21 days 2 animals appeared to have completely recovered, 3 animals presented “Light brown discolouration of skin; probably not permanent effect” but the remaining one presented “treated skin thickened and discoloured (purple); probably permanent effect”. Although on the basis of the group mean 24, 48 and 72 hour scores for erythema and oedema (2.7 and 1.9, respectively) the test material would be classified as a moderate irritant, this scheme is clearly inappropriate in this case where the skin responses increased with time up to and including 7 days post-dosing and one animal developed irreversible skin effects.
Under the conditions of this study the test material caused irreversible damage to the skin of one rabbit and is therefore considered to be corrosive.
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