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EC number: 219-371-7 | CAS number: 2425-79-8
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- reliability scoring based on 2001 guideline
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA test protocol was available
Test material
- Reference substance name:
- 1,4-bis(2,3-epoxypropoxy)butane
- EC Number:
- 219-371-7
- EC Name:
- 1,4-bis(2,3-epoxypropoxy)butane
- Cas Number:
- 2425-79-8
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,4-Butanedioldiglycidylether (BDDGE)
- Physical state: liquid
- Analytical purity: 97.1%
- Lot/batch No.: DC 1294.2
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI SPF
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 314 to 346 g
- Housing: individually in Makrolon type-3 cages
- Diet (e.g. ad libitum): pelleted standard ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15/hr
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: bi-distilled water
- Concentration / amount:
- 1) Induction:
Intradermal injection: 1% (with bi-distilled water) of 0.1 mL
Epidermal application: 10% (in bi-distilled water) on a saturated 2 x 4 cm patch of filter paper
2) Challenge: 5% in bi-distilled water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: bi-distilled water
- Concentration / amount:
- 1) Induction:
Intradermal injection: 1% (with bi-distilled water) of 0.1 mL
Epidermal application: 10% (in bi-distilled water) on a saturated 2 x 4 cm patch of filter paper
2) Challenge: 5% in bi-distilled water
- No. of animals per dose:
- Range finding tests: 1 male and 1 female for the intracutaneous test and 6 males and 5 females for the epicutaneous tests.
Main study: 5 animals/sex for control group and 10 animals/sex for the test group - Details on study design:
- RANGE FINDING TESTS: The objective of preliminary study was to identify irritation test article concentrations suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
1) Intradermal injections: Intradermal injections (0.1 mL/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3, and 1% of the test article in bi-distilled water. The resulting dermal reactions were assessed 24 hours later.
2) Epidermal application: Patches of filter paper (2 x 2 cm) were saturated with concentrations of 25, 15, 10, and 5% of the test article in bi-distilled water and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema on a numerical basis according to the scale 24 and 48 hours after removal of the dressings. Two previous epidermal pre-tests were performed as described above, one with the undiluted test article and 75, 50, and 25% test article in vaseline, the second with the same concentrations in bi-distilled water. This latter was performed because the test article was not miscible in vasilne. The third epidermal pre-test described above was performed to confirm the previous results and to determine the slightly irritating and highest non-irritating concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
I) Intradermal Injections:
An area of dorsal skin from the scapular region was clipped free of hair. Three pairs of intradermal injections (0.1mL/site) were made at the border of a 4 x 6 cm area in the clipped region as follows:
-Test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water;
2) The test article, diluted to 1% with bi-distilled water; and
3) The test article diluted to 1% with bi-distilled water, emulsified in a 50:50 mixture of Freund's complete adjuvant and bi-distilled water.
-Control group:
1) Freund's complete adjuvant 50:50 with bi-distilled water;
2) Bi-distilled water; and
3) Freund's complete adjuvant 50:50 with bi-distilled water.
II) Epidermal Applications:
-Test group:
One week after the injections, the scapular area was again clipped and shaved free of hair. A 2 x 4 cm patch of filter paper was saturated with the test article (10% in bi-distilled water) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for approximately 48 hours. Reaction sites were assessed for erythema and edema 24 and 48 hours after removal of the dressing, using the numerical grading system.
-Control group:
The guinea-pigs of the control group were treated as described above with the omission of test article.
B. CHALLENGE EXPOSURE
The test and control guinea-pigs were challenged 2 weeks after the epidermal induction application. Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig.
-Test group:
Two patches of filter paper were saturated with:
a) non-irritant concentration (5% in bi-distilled water) of the test article and
b) with the vehicle only
and applied to the left flank and right flank using the same method as for the epidermal application.
The dressings were removed approximately 24 hours later. The sites were assessed for erythema and edema 24 and 48 hours after removal of the dressing, using the numerical scoring system as described under preliminary study. Erythema and edema reactions were described. The challenge site was evaluated 24 and 48 hours after removal of the patch. The readings were made under artificial fluorescent light (daylight spectrum). The reactions were scored on the basis of the Draize score. Based upon the percentage of animals sensitised (24-hour reading), the test article was assigned to one of the following 5 grades of allergenic potency, ranging from weak to extreme.
Sensitisation rate (%): Grade: Classification
0 - 8: 1: Weak
9 - 28: 2: Mild
29 - 64: 3: Moderate
65 - 80: 4: Strong
81 - 100: 5: Extreme
-Control group:
The control animals were treated in the same way as described above.
OTHER: Erythema and edema were assessed using the following numerical grading system according to Draize:
Erythema and eschar formation:
No erythema:0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Edema formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well-defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure): 4 - Challenge controls:
- See details on study design.
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde
Results and discussion
- Positive control results:
- For the induction period, a 20% dilution of formaldehydesung (HCHO) in bi-distilled water and for the challenge procedure, a 15% dilution of HCHO was used. Clear positive results were observed in the HCHO-treated animals after the epidermal challenge application (7 positive reactions among 10 animals tested). According to the results observed, it is considered that HCHO possess an strong skin sensitising (contact allergenic) potential in the guinea pig strain used (Ibm: GOHI; SPF-quality).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% . No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 15%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: not reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 15%. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: not reported.
Any other information on results incl. tables
Sensitizing Effects
CONTROL GROUP:
Two out of 10 and 1 out of 10 animals showed spontaneous positive erythema reactions after the first challenge when treated with the 5% test article dilution at the 24- and 49-hour reading, respectively. No positive erythema reactions were observed with bi-distilled water alone.
TEST GROUP:
Seventeen out of 20 and 15 out of 20 animals showed positive erythema reactions after the first challenge when treated with the 5% test article dilution at the 24- and 48-hour reading, respectively. No positive erythema reactions were observed with bi-distilled water alone.
MORTALITY/VIABILITY
No death occurred during the study.
SYMPTOMS, LOCAL
CONTROL GROUP:
Application area around the injection sites 1and 3 was found to show erythema and edema from day 2 to 7; necrosis were observed from day 8 to 21 and encrustations from day 20 to 31. No local symptoms were observed in injection site 2.
TEST GROUP:
Application area around the injections sites 1, 2 and 3 was found to show the same local symptoms as described above for the injections sites1 and 3 of control group.
On day 9 of test no observation could be performed because the animals were bandaged semi-occlusively.
SYMPTOMS, SYSTEMIC
No systemic symptoms were observed in the animals.
BODY WEIGHTS
The body weight gain of the animals was not affected adversely during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- From the results of this OECD 406 study a "strong" allergenic potency of the test article 1,4-butanediol digylcidyl ether (BDDGE) was concluded. The results were interpreted according to the rating of Magnusson and Kligman (1969). However, the test article was not classified as an "extreme" sensitizer, because 20% of the control animals showed positive erythema reactions at the 24-hour reading.
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