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EC number: 205-771-9 | CAS number: 150-78-7
- Life Cycle description
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- Endpoint summary
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- Endpoint summary
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- 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
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- 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
Paradimethoxybenzene is slightly irritating to the eyes and not irritating to the skin in tests on rabbits, following OECD guidelines.
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 27 feb 2007 to 29 may 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Harlan Netherlands BV
Kreuzelweg 53
NL-5961 NM Horst / The Netherlands
Postbus 6174
NL-5960 AD Horst / The Netherlands
- Age at study initiation: 11 weeks (male); 11, 12 weeks (females)
- Weight at study initiation: between 2.3 to 3 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 83/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12. Music was played during the daytime light period.
IN-LIFE DATES: From 27 feb 2007 to 02 mar 2007 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: purified water
- Controls:
- other: the other flank served as control
- Amount / concentration applied:
- Concentration: 0.5 g
Concentration: moistened with purified water (0.5 ml)
pH: 6.84
- VEHICLE: purified water to moisten Paradimethoxybenzene - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3: 1 male and 2 females
- Details on study design:
- TEST SITE:
- Area of exposure: on left flank
- % coverage: 6.25 cm²
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE:
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according the Commission Directive 2004/73/EC april 29, 2004; and Directive 2001/59/EC, august 2001 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this test, the substance is not irritating
- Executive summary:
In a primary dermal irritation study (RCC study number B16075), New Zealand White rabbits (1 male and 2 females) were dermally exposed to 0.5 g of Paradimethoxybenzene moistened with purified water for 4 hours to 6.25 cm² on left flank.
Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The scores were 0 for edema and 0 for erythema.
In this study, Paradimethoxybenzene is not a dermal irritant according to the EU classification criteria.
Reference
Table of results:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
Reversibility*) |
No effects |
No effects |
Remark: The
animals were not sacrificed. On completion of the observation period
they were re-allocated to the eye irritation study (RCC Study B16086).
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:
- from 02 mar 2007 to 29 may 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Harlan Netherlands BV
Kreuzelweg 53
NL-5961 NM Horst / The Netherlands
Postbus 6174
NL-5960 AD Horst / The Netherlands
- Age at study initiation: 15 weeks (male); 13, 14 weeks (females)
- Weight at study initiation: between 2.6 to 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 83/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12. Music was played during the daytime light period.
IN-LIFE DATES: From 07 or 08 mar 2007 to 12 mar 2007 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- - TEST MATERIAL:
Amount applied: 0.1 g
Concentration: pure
pH: 6.84 - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3: 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: according the Commission Directive 2004/73/EC april 29, 2004 - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Other effects:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and
chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual
mean scores for the conjunctivae were 0.33, 0.33 and 0.67 for reddening, respectively and 0.00 for chemosis for the three animals. No abnormal
findings were observed in the cornea or iris of any animal at any of the measurement intervals. A slight to moderate reddening of the conjunctivae
was noted in all animals at the 1-hour observation and persisted as slight up to the 24-hour reading in two animals and up to the 48 -hour
observation in one animal. Additionally, all animals expressed a slight reddening of the sclera 1 hour after instillation, which persisted in one female 24 hours later. Slight to moderate discharge was recorded in all three animals at the 1 -hour reading. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study (RCC study number B16086), 0.1 g of Paradimethoxybenzene was instilled into the conjunctival sac of left eye of New Zealand White rabbits (1 male and 2 females). Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.33 and 0.67 for reddening, respectively and 0.00 for chemosis for the three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals In this study, Paradimethoxybenzene is not an eye irritant based on the EU classification criteria.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 29 nov 1988 to 02 dec 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 3 kg
- Housing: individually in cages, fully air-conditioned
- Diet: Altromin 2123 rabbit diet (Altromin GmbH) ad libitum, and hay ad libitum (approx. 15 g/day).
- Water: desionised water ad libitum
- Acclimation period: no data.
24 h before testing the eyes of the animals were treated with some drops of Florescein-Sodium-solution (0.01 &%) and checked for damages under UV-light. Only animals with eyes showing no damages were used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): Air-conditioned room
- Photoperiod (hrs dark / hrs light): 12h / 12h daily - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- 100 mg of test substance into conjunctival sack of the left eye, one single application.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours.
Points at 1, 24, 48 and 72 hours. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): saline solution
- Time after start of exposure: 24 hours
- check after 24 and 72 h:
after instillation of one drop of Flurorescein-sodium-solution (0.01 %) the cornea was checked under UV-light
SCORING SYSTEM: according to the OECD 405 guideline
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: No effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: No effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: No effect
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Paradimethoxybenzene is not irritating to the eyes.
- Executive summary:
In a primary eye irritation study (Hoechst, 1988), 0.1 g of Paradimethoxybenzene was instilled into the conjunctival sac of left eye of New Zealand White rabbits (3 animals). Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The mean score was calculated across 3 scoring times, 24, 48 and 72 hours after instillation for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
The mean scores at 24, 48 and 72 hours for iris and Chemosis were 0. The mean scores at 24, 48 and 72 hours for the conjunctivae were 0.33, and for corneal opacity, 0.11.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
In this study, Paradimethoxybenzene is not an eye irritant based on the EU classification criteria.
Referenceopen allclose all
Result table:
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/2 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.33/0.33/0.67 |
0 |
Reversibility*) |
No effects |
No effects |
fully |
No effects |
Result table:
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
2/2/2 |
2/2/1 |
24 h |
1/0/0 |
0/0/0 |
1/1/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
1/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.33/0/0 |
0 |
0.66/0.33/0 |
0 |
Reversibility*) |
fully |
No effects |
fully |
No effects |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
Four studies were available and two studies with reliability 1 were selected, one as key study and the second one as supporting study.
In
the first primary dermal irritation study (RCC study number B16075) (key study),
New Zealand White rabbits (1 male and 2 females) were dermally exposed
to 0.5
g of
Paradimethoxybenzene moistened with purified water for 4 hours to 6.25
cm² on left flank. Test sites were covered with a semi-occlusive
dressing for 4 hours. Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The scores were 0 for edema and 0 for erythema.
In the second one (Clariant, 1988) (supporting study), animals were tested with the same manner.
The mean scores at 24, 48 and 72 hours were 0 for edema and 0,2 for erythema.
In these studies, Paradimethoxybenzene is not a dermal irritant according to the EU classification criteria.
Eye:
Two studies with validity 1 were selected as key studies.
In the first primary
eye irritation study (RCC study number B16086),0.1
g of
Paradimethoxybenzene was instilled into the conjunctival sac of left eye
of New Zealand White rabbits (1 male and 2 females). Animals then were
observed for 72 hours. Irritation was scored according to the EU
classification criteria.
The mean score was calculated across 3 scoring times (24, 48 and 72
hours after instillation) for each animal for corneal opacity, iris,
redness and chemosis of the conjunctivae, separately. The individual
mean scores for chemosis, corneal opacity and iris were0.00for
all three animals.
The individual mean scores for the conjunctivae were 0.33, 0.33 and 0.67, respectively.
No abnormal findings
were observed in the cornea or iris of any animal at any of the
measurement intervals.
In the second primary eye irritation study (Hoechst, 1988), 0.1 g of Paradimethoxybenzene was instilled into the conjunctival sac of left eye of New Zealand White rabbits (3 animals). Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The mean score was calculated across 3 scoring times, 24, 48 and 72 hours after instillation for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
The mean scores at 24, 48 and 72 hours for iris and chemosis were 0 for all three animals.
The individual mean scores at 24, 48 and 72 hours for the conjunctivae were 0.66, 0.33 and 0, and 0.33, 0 and 0 for corneal opacity.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
In these studies, Paradimethoxybenzene is not an eye irritant based on the EU classification criteria.
Justification for classification or non-classification
Based on the two reliable studies, the substance is not classified irritant for the skin according to EU and UN GHS criteria.
Based on the two reliable studies, the substance is not classified irritant for the eyes according to EU and UN GHS criteria.
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