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EC number: 202-785-7 | CAS number: 99-76-3
- 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

Endpoint summary
Administrative data
Description of key information
Skin irritation:
3 studies (1 key study/2 supporting studies) available: mildly/not irritating
Eye irritation:
1 study available: minimally transient irritant
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:
- December 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to primary skin irritation test design in effect since 1976, but not according to OECD Guideline.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary skin irritation test design in effect since 1976.
The method is a modification of the Draize technique and is similar to that used in grading skin irritation in the Human Patch Test. The highest grade at either the 2 or 24 hour reading is used to calculate the Primary Irritation Index (PII). - GLP compliance:
- no
- Remarks:
- study performed before GLP guidelines
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Specie: Albino rabbit
- Sex: female
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Frequency: once
- Product type: per se
- Concentration tested: 100%
VEHICLE: none - Duration of treatment / exposure:
- 24 hrs
Then the occlusive dressing was removed. - Observation period:
- 24 and 72 hrs after contact
- Number of animals:
- 9
- Details on study design:
- METHODS:
Nine healthy female albino rabbits were used to study each material.
The test material was applied to a 1" filter disc which was held in contact with the clipped skin of the back of the animal by Blenderm tape. The trunk of each animal was then wrapped with an occlusive plastic sheet and secured with Elastoplast tape.
OBSERVATIONS:
The occlusive dressing was removed after 24 hours of contact, and the skin sites graded for irritation and edema after 24 and 72 hours according to the scoring system based on a maximum of
PSI Scores:
0 = no evidence of any effect
1/2 = (Barely Perceptible) = minimal faint uniform or spotty erythema
1 = (Mild) = pink uniform erythema covering most of contact site
2 = (Moderate) = Pink-red erythema visibly uniform in entire contact area
3 = (Marked) = Bright red erythema with accompaning edema, petachiae or papules
4 = (Severe) = Deep red erythema with vesiculation or weeping with or withourt edema
PSI = Primary Skin Irritation Score, Maximum Score = 4.0
PII = Primary Irritation Index - a value depicting the average skin response of the test panel as a whole. It is calculated by adding the Irritation Scores and dividing by the total number of test subjects. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: test item; readings performed after 24 and 72 h
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: control; readings performed after 24 and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n.a.
- Remarks on result:
- other: no evidence of any effect; readings performed after 24 and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: 2-7
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: minimal faint uniform or spotty erythema; readings performed after 24 and 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal: 8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: pink uniform erythema covering most of contact site
- Irritation parameter:
- erythema score
- Basis:
- animal: 9
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: pink-red erythema visibly uniform in entire contact area
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n.a.
- Remarks on result:
- other: readings performed after 24 and 72 h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, when evaluated for primary skin irritation by a 24-hour patch test conducted on intact skin, was found to be not irritating.
- Executive summary:
The test material, when evaluated for primary skin irritation by a 24-hour patch test conducted on intact skin, was found to be not irritating to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1956
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only discussion of experimental results, but no detailed data available
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- application of methylparabene dissolved in propylene glycol to the skin of 50 human subjects
- GLP compliance:
- no
- Remarks:
- study performed before GLP guidelines
- Species:
- human
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: propylene glycol
- Controls:
- no
- Amount / concentration applied:
- 5% solution of methylparaben in propylene glycol;
amount: no data - Duration of treatment / exposure:
- Application during a period from four to eight hours every other day and a total of ten applications.
- Observation period:
- no data
- Number of animals:
- 50 human subjects
- Details on study design:
- The methyl ester of p-hydroxybenzoic acid was dissolved in propylene glycol in increasing concentrations, and applied to the skin of 50 human subjects. It was found that the following concentration produced no irritation when applied during a period from four to eight hours every other day and a total of ten applications.: 5%. Higher concentrations produced some evidence of irritation.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: not defined
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: not defined
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information in concentrations up to 5% in propylene glycol Criteria used for interpretation of results: not specified
- Conclusions:
- Methylparaben was found to be not irritant when applied dissolved in propylene glycol in concentrations up to 5% to the skin of humans.
- Executive summary:
Methylparaben was found to be not irritant when applied dissolved in propylene glycol in concentrations up to 5% to the skin of humans.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1952
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only discussion of experimental results, but no detailed data available
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 10% paste of methylparaben in a hydrophilic ointment base were applied to the skin of rabbits.
- GLP compliance:
- no
- Remarks:
- study performed before GLP guidelines
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- test animal: white rabbits
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: hydrophilic ointment base
- Controls:
- no
- Amount / concentration applied:
- 10% hydrophilic ointment base
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- no data
- Number of animals:
- no data
- Details on study design:
- 10 per cent pastes of methyl 4-hydroxybenzoate in a hydrophilic ointment base were applied to the skin of the backs of white rabbits.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Methylparaben was found to be not irritating when applied as 10% paste in hydrophilic ointment to the skin of white rabbits.
- Executive summary:
Methylparaben was found to be not irritating when applied as 10% paste in hydrophilic ointment to the skin of white rabbits.
Referenceopen allclose all
SCORE | 0 | 1/2 | 1 | 2 | 3 | 4 |
Number of Animals Test | 1 | 6 | 1 | 1 | 0 | 0 |
Control | 4 | 2 | 3 | 0 | 0 | 0 |
No irritation was observed up to a concentration of 5%.
Higher concentrations produced some evidence of irritation.
There was no noticable irritation detected after forty-eight hours.
Upon sacrificing the animals, no Parasepts or degredation products thereof were detected in the kidneys.
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:
- December 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to Eye irritation test design (modified Draize), but not according to OECD Guideline.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Eye irritation test design (modified Draize).
Examinations for injuries or irritation will be made until all eyes are negative or for seven days, whichever occurs first. - GLP compliance:
- no
- Remarks:
- study performed before GLP Guidelines
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Specie: Albino rabbit/New Zealand
- Sex: males and/or females
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Frequency: once
- Product type: per se
- Concentration tested: 100%
VEHICLE: none - Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 48 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- METHODS:
Six healthy albino rabbits, males and/or females, were used.
The test material was instilled into one eye of each animal; the other eye served as the control.
OBSERVATIONS:
Examinations for injuries were made at 24, 48, and 72 hours and at four and seven days.
Observations of injuries or irritation resulting from contact with these substances were made on the cornea, iris, and conjunctiva.
Eye irritation was graded and scored according to the scoring system of Draize, J. H., from the Appraisal of the Safety of Chemicals in Foods, drugs, and Cosmetics, association of Food and Druf Officials of the U.S., Austin, Texas, 1959.
Maximum score = 110 - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Day 1
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Day 2
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: mean score on cornea opacity, iris, chemosis and conjunctivae
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Methylparaben produced slight transient irritation with an eye irritation score of 1/110 on Day 1 when applied to the eyes of rabbits which was fully reversible within 48 h.
- Executive summary:
Methylparaben produced slight transient irritation with an eye irritation score of 1/110 on Day 1 when applied to the eyes of rabbits. This effect was fully reversible within 48 h.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Three studies are available that examined the skin irritancy potential of Methylparaben. For two of them only basic facts are reported but one detailed study clearly demonstrates that the skin irritation potential is minimal to negligible. This conclusion is consistently supported by the other studies which did not show any skin irritation after Methylparaben treatment in humans and rabbits.
There is limited data available on the eye irritancy potential. The study was performed according to the Eye Irritation Test Design (modified Draize) and reported in sufficient detail to be able to ascertain that the substance has very low eye irritancy potential (irritation score 1/110, 6 animals), with effects disappearing within 48 hours of instillation of the substance into rabbit eyes.
Justification for classification or non-classification
The substance is not irritating to the skin following single application and does not meet the criteria for classification as a skin irritant.
There is limited but sufficient data available on the eye irritancy potential to conclude that the substance does not meet the criteria to be classified as irritating to the eye.
It can reasonably be deduced that Methylparaben does not cause respiratory tract irritation and thus does not have to be classified, because the substance did cause only slight, fully reversible irritative effects in the eyes and the skin. It does not have to be classified as either skin or eye irritating. Therefore, Methylparaben, in the unlikely event of being inhaled as a dust, is considered not to cause severe effects, due to its not- irritating properties on skin and eye. A harmful interaction with living cells and tissues is very unlikely (as demonstrated by the in vivo skin and eye irritation studies).
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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