Registration Dossier
Registration Dossier
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EC number: 905-459-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
- Skin irritation: not irritating (weight of evidence)
- Eye irritation: not irritating (weight of evidence)
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:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Guideline:
- other: Study from 1976 (no guidelines available at the time the study was performed).
- Principles of method if other than guideline:
- Draize test: 6 New Zealand Albino rabbits were dosed with 0.5 mL of undiluted TS over 24 hrs.
- GLP compliance:
- no
- Remarks:
- Study from 1976 (GLP was not compulsory at the time the study was performed).
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No further data
- Type of coverage:
- other:
- Preparation of test site:
- other: intact / abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of undiluted TS
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 168 hrs
- Number of animals:
- 6
- Details on study design:
- No further data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 72 hrs average
- Score:
- 6.5
- Max. score:
- 8
- Reversibility:
- fully reversible within: 168 hrs
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The TS was classified as severely skin irritating (24-hr exposure instead of 4-hr in the guideline).
- Executive summary:
In this older study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.5 mL of undiluted TS over 24 hrs to intact or abraded skin. The irritation score (24, 72 hrs average) was given with 6.5 and the effects were fully reversible within 168 hrs. The TS was in fine not classified as skin irritating in 4h.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- original publication in Czech, Only results given
- Principles of method if other than guideline:
- no data. 24 hour exposure
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- no data
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no details
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- no data
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no details
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Documentation insufficient for assessment (only results given), concluding to non skin irritation
- Executive summary:
This supportive study, confirm the weight of evidence for non irritation in 4 hours on normal rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre
- Age at study initiation: 4-9 months
- Weight at study initiation:
- Housing: singly housed in hanging, stainless-steel cages with allmesh floors and tops and half-mesh fronts; each cage measured 67 cm x 43 cm x 45 cm
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 °C
- Humidity (%):
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2 cm x 2 cm
- Type of wrap if used: the patch and surrounding skin were covered by a single layer of gauze and held in place by means of an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
at 30 minutes after the removal of the patch (i.e. approximately 4 hours after application) and at 24, 48 and 72 hours and at 7 and 14 days after patch removal
SCORING SYSTEM:
- Method of calculation: The site was examined and scored for erythema and oedema on a graded scale of 0 to 4. The mean score of each rabbit at each observation time and the group mean score of the 24, 48'and 72 hours post-dosing readings were calculated. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- By 24 hours post-dosing all rabbits had slight inflammation of the treated sites which progressed to moderate inflammation at 48 and 72 hours. The responses at 7 days post-dosing were similar to those observed at 24 hours but by 14 days all skin reactions had cleared. The group mean 24, 48 and 72 hour scores for erythema and oedema were 2.1 and 0.8 respectively.
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Based on this study, 1,3-DIPB is considered as mild irritant, but not classified according to CLP criteria (Cat. 3 of GHS)
- Executive summary:
In this study, 6 New Zealand Albino rabbits were dosed with 0.5 mL of pure 1,3-DIPB over 4 hrs to the shaved skin under semi-occlusive conditions.
By 24 hours post-dosing all rabbits had slight inflammation of the treated sites which progressed to moderate inflammation at 48 and 72 hours. The responses at 7 days post-dosing were similar to those observed at 24 hours but by 14 days all skin reactions had cleared.
The group mean 24, 48 and 72 hour scores for erythema and oedema were 2.1 and 0.8 respectively.
On the basis of these scores the test material is not considered as a skin irritant according to CLP criteria.
Referenceopen allclose all
Erythema (I / A) |
Oedema (I / A) |
|||||||||
Hours |
4 |
24 |
48 |
72 |
168 |
4 |
24 |
48 |
72 |
168 |
Animal No. |
||||||||||
1 |
2/2 |
3/4 |
3/4 |
3/3 |
0/0 |
2/2 |
3/4 |
2/3 |
1/2 |
0/0 |
2 |
2/2 |
4/4 |
4/4 |
4/4 |
0/0 |
2/2 |
4/4 |
3/3 |
3/3 |
0/0 |
3 |
2/2 |
4/4 |
4/4 |
4/4 |
0/0 |
2/2 |
4/4 |
3/3 |
2/2 |
0/0 |
4 |
2/2 |
4/4 |
4/4 |
3/3 |
0/0 |
2/2 |
4/4 |
3/3 |
2/2 |
0/0 |
5 |
2/2 |
4/4 |
4/4 |
3/4 |
0/0 |
2/2 |
4/4 |
3/3 |
2/3 |
0/0 |
6 |
2/2 |
3/3 |
3/3 |
3/3 |
0/0 |
2/2 |
3/3 |
2/2 |
2/2 |
0/0 |
I = intact; A = abraded
Defatting effect: skin sloughed off in 10 - 14 days. No injury in depth.
| Response at stated time after application | Erythema | Oedema |
| 4 hours | 0.5/0.5/0.5/0.5/0.5/0.5 | 0/0/0/0/0/0 |
| 24 hours | 1.5/2/1.5/1/2/1.5 | 0.5/0.5/0.5/0.5/0.5/0.5 |
| 48 hours | 3/3/2/1.5/2.5/2.5 | 1/1/1/0.5/1/1 |
| 72 hours | 3/2.5/2.5/1.5/2.5/2.5 | 1/1/1/0.5/1/1 |
| 7 days | 1.5/1.5/2/0.5/2/1.5 | 0.5/0.5/1/0/1/0.5 |
| 14 days | 0/0/0/0/0/0 | 0/0/0/0/0/0 |
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:
- weight of evidence
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Guideline:
- other: Study from 1976 (no guidelines available at the time the study was performed).
- Principles of method if other than guideline:
- Draize test: 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs.
- GLP compliance:
- no
- Remarks:
- Study from 1976 (GLP was not compulsory at the time the study was performed).
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No further data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL of undiluted TS
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 168 hrs
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- No further data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 4.8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: score=2x(Redness+Chemosis+Discharge) (no detail)
- Irritation parameter:
- chemosis score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The TS was classified as slightly eye irritating (GHS criteria not met).
- Executive summary:
In this older study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted TS over 24 hrs. The irritation score (24, 48, 72 hrs average) was given with 3.2/110 and the effects were fully reversible within 72 hrs. The TS was classified as slightly irritant to the eyes (GHS criteria not met).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 24 hour exposure
- GLP compliance:
- not specified
- Species:
- rabbit
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- other:
- Remarks:
- no data
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details
- Irritation parameter:
- iris score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details
- Irritation parameter:
- conjunctivae score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details
- Irritation parameter:
- chemosis score
- Basis:
- other: no data
- Time point:
- 24/48/72 h
- Remarks on result:
- other: no details
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Documentation insufficient for assessment (only results given), but results indicate no final irritation
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984-1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre
- Age at study initiation: 4-9 months
- Weight at study initiation:
- Housing: singly housed in hanging, stainless-steel cages with allmesh floors and tops and half-mesh fronts; each cage measured 67 cm x 43 cm x 45 cm
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 16-19 °C
- Humidity (%):
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: similar to OECD guideline
A visual assessment of eye irritancy was made at I hour, 24 hours, 48 hours, 72 hours and 7 days after instillation. Irritancy was scored for the cornea, iris and conjunctivae using the standard scores.
The group mean 24, 48 and 72 hour scores for corneal opacity. iritic effects and conjunctival redness and chemosis were calculated.
TOOL USED TO ASSESS SCORE: visual assessment and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- All rabbits showed very slight conjunctival redness and some also had very slight chemosis and/or discharge; these latter two effects were only observed at 1 hour after dosing.
The group mean 24. 48 and 72 hour scores were 0.3 for redness and zero for chemosis, corneal opacity and lritic effects. - Other effects:
- The instillation of undiluted 1,3-DIPB into the conjunctival sac of one eye of each of six rabbits resulted in moderate initial pain.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study, 1,3-DIPB is not considered as irritating to the eyes in rabbits.
- Executive summary:
In this study (similar to OECD guideline and GLP), the instillation of undiluted 1,3-DIPB into the conjunctival sac of one eye of each of six
rabbits resulted in moderate initial pain. All rabbits showed very slight conjunctival redness and some also had very slight chemosis and/or
discharge; these latter two effects were only observed at 1 hour after dosing.
The group mean 24, 48 and 72 hour scores were 0.3 for redness and zero for chemosis, corneal opacity and lritic effects.
The test material therefore is not classified as an eye irritant according to CLP and GHS criteria.
Referenceopen allclose all
Hours |
||||||
1 |
24 |
48 |
72 |
120 |
168 |
|
Mean score (X/110) |
10.3 |
6.6 |
3.0 |
0.0 |
0.0 |
0.0 |
Irritation score (24, 48, 72 hrs average): 3.2
Immediate: slight discomfort
10 min: slight to moderate erythema, copious discharge
1 h: slight to moderate erythema, very slight oedema, copious discharge
24 hrs: slight erythema, moderate to copious discharge
48 hrs: gradual improvement
72 hrs: all scored zero
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
In an old study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.5 mL of undiluted DIPB over 24 hrs to intact or abraded skin. The irritation score (24, 72 hrs average) was given with 6.5 and the effects were fully reversible within 168 hrs.
Two supportive studies confirm the weight of evidence for non irritation in 4 hours on normal rabbit skin.
The TS was in fine not classified as skin irritating in 4h.
Eye irritation
In an old study (Draize test), 6 New Zealand Albino rabbits were dosed with 0.1 mL of undiluted DIPB over 24 hrs. The irritation score (24, 48, 72 hrs average) was given with 3.2 and the effects were fully reversible within 72 hrs. The TS was classified as slightly irritant to the eyes (GHS criteria not met).
Two supportive studies confirm this result.
Justification for classification or non-classification
Based on the classification criteria of UN/EU GHS, the results obtained in rabbits for dermal and eye irritation do not warrant a classification of DIPB for skin and eye irritation.
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