Registration Dossier
Registration Dossier
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EC number: 947-827-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on results of the Magnusson & Kligman test in guinea pigs (acc. to OECD 406) with two analogue substances it is predicted that the test substance has no skin sensitizing properties. This study data from two analogue substances are used for read across as identical /similar metabolites presumed after enzymatic hydrolysis. Therefore, read across is justified.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-04-25 to 2012-07-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study. This study data from Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts Variante TEA/Na Salz i.e. an analogue substance, are used for read across as identical /similar metabolites presumed after enzymatical hydrolysis. Therefore, read across is justified.
- Justification for type of information:
- Rationale for the read-across: Refer to IUCLID Chapter 13 "Assessment reports", Read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test substance is a surfactant. The surface tension is 30.6 mN/m at 1g/L and 20°C. The LLNA test is not a sufficant test system for surfactants.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Semi barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs (lot no. 0950), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding (lot no. 261111)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- For the intradermal injection (induction - first stage), 0.1 g of the test item was dissolved in 0.9% NaCl to gain a final volume of 10 mL of a 1% solution (w/v).
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- For the topical application (induction – second stage), 3 g of the test item were dissolved in 0.9% NaCl
to gain a final volume of 6 mL of a 50% solution (w/v). - Day(s)/duration:
- Day 7, duration 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- For the topical application (challenge), 3.13 g of the test item were dissolved in 0.9% NaCl to gain a final volume of 25 mL of a 12.5% solution (w/v).
- Day(s)/duration:
- Day 20, duration 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 test animals, 5 control animals and 5 animals for preliminary study
- Details on study design:
- Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the midline.
Test Group: Day 0
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: a 1% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 1% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Control Group: Day 0
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% physiological saline 0.9% NaCl
Injection 3: a 50% (v/v) formulation of 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Injections 1 and 2 were given close to each other and nearest to the head, while injection 3 was given toward the caudal part of the test area.
Induction: Second Stage, Topical Application
Test Group and Control Group: Day 6
Approximately twenty-four hours before the topical application the test area was painted with 0.5 g of 10% sodium lauryl sulphate
in vaseline after close clipping in order to create a local irritation.
Test Group: Day 7
The test item was dissolved in physiological saline 0.9% NaCl at a concentration of 50%. A patch was fully loaded with 0.5 mL of the
prepared test item. Then it was applied to the test area and held in contact with the help of an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was fully loaded with 0.5 mL of physiological saline 0.9% NaCl. Then it was applied to the test area and held in contact with
the help of an occlusive dressing for 48 hours. - Challenge controls:
- The flanks of treated and control animals were cleared of hair by close-clipping.
Test Group and Control Group: Day 20
The test item was dissolved in physiological saline 0.9% NaCl at a concentration of 12.5%. A patch, loaded with 0.5 mL
of the prepared test item was applied to the left flank of the animals and a patch loaded with 0.5 mL of the vehicle to the right flank
(intraspecific control). The patches were held in contact with the help of an occlusive dressing for 24 hours.
The application area was not rinsed.
Observation
Test Group and Control Group
Approximately 20 hours after removing the patch, the challenge area was cleared of hair by the use of a depilatory cream.
Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded according to the grades shown below.
Additionally all animals were observed for signs of toxicity at least once daily during the test period. - Positive control substance(s):
- not required
- Remarks:
- performed periodically every 6 months
- Positive control results:
- The recent reliability check was performed in March/April 2012. The raw data of this study are kept in the BSL archives (BSL Project ID 120793).
The reliability checks are audited by the QA-unit periodically.
Positive-control substance: mercaptobenzothiazole, purity > 98%,
Fluka Chemica, Lot No. 41107195, expiry date: 20/01/2014
Concentrations: 2% induction I phase (in cottonseed oil)
25% induction II phase (in vaseline)
15% challenge (in Vaseline)
The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (15% in vaseline)
was 100%, confirming the reliability of the test system. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor oedema was observed in any animal at any time of observation.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor oedema was observed in any animal at any time of observation. The body weight development was within the biological range for all animals compared to historical data. All animals of both groups survived throughout the test period.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitization potential was investigated according to the OECD Guideline 406. No significant skin sensitization potential was found. No classification is warranted.
- Executive summary:
The skin sensitization potential of Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts was investigated according to the OECD Guideline 406. No significant skin sensitization potential was found. No classification is warranted. The induction doses were 1 % and 50% for intradermal and epidermal respectively. The challenge was performed at the concentration of 12.5%. None of the treated 10 animals responded upon challenge. Based on the obtained result, Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts is considered to be a non skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993-04-27 to 1993-05-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- OECD guideline and GLP conform well documented scientific study report. This study data from a salt of an alkenyl succinic acid derivative, i.e. an analogue substance, are used for read across as identical /similar metabolites presumed after enzymatical hydrolysis. Therefore, read across is justified.
- Justification for type of information:
- Justification is provided in a separate statement.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed prior to implementation of LLNA Test Guideline.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Pretest for primary irritancy
- dermal: 25, 5, 1, 0.2 % in isotonic saline
- intradermal injections: 5, 1, 0.2 % in isotonic saline
Main test:
- Induction - intradermal injection:
0.2 % solution of test substance in isotonic saline.
Induction - dermal application (occlusive):
1 % test substance preparation
- Dermal challenge treatment:
0.2 % test substance in isotonic saline - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Pretest for primary irritancy
- dermal: 25, 5, 1, 0.2 % in isotonic saline
- intradermal injections: 5, 1, 0.2 % in isotonic saline
Main test:
- Induction - intradermal injection:
0.2 % solution of test substance in isotonic saline.
Induction - dermal application (occlusive):
1 % test substance preparation
- Dermal challenge treatment:
0.2 % test substance in isotonic saline - No. of animals per dose:
- Control group: 10 animals
Treatment group: 20 animals - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2% in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none described
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2% in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none described.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.2 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none described
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.2 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none described.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none described
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none described.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.2 % in isotonic saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none described
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 % in isotonic saline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none described.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the reults of this study the test substance showed no evidence for sensitizing properties.
- Executive summary:
In order to determine the sensitizing potential of the test substance an OECD 406 Magunsson &Kligman test in guinea pigs was performed. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, twenty experimental animals were intradermally injected with a 0.2% test concentration in isotonic saline and epidermally exposed to a 1% concentration. Ten control animals were similarly treated, but with vehicle alone (isotonic saline). The application area was kept for 48 hours under an occlusive bandage. Due to strong irritation reaction of the skin at 1% , 10% SDS was not applied at day 7 prior to challenge treatment. Two weeks after the epidermal application all animals were challenged with a 0.2% test substance concentration and the vehicle. The application area was kept under occlusive conditions for 24 hours. No skin reactions were evident after the challenge exposure in the experimental and control animals.
There was no evidence that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in response to a 0.2% test substance concentration in isotonic saline in the challenge phase. This result indicates a sensitization rate of 0 per cent. Based on these results the test substance does not have to be classified.
Referenceopen allclose all
Preliminary Test
1 animal was treated intradermally with concentrations of 1%, 1.5%, 2.5% and 5% of the test item (dissolved in physiological saline 0.9% NaCl).
1 animal was treated topically with concentrations of 50% (emulsified with vaseline)and 100% (undiluted) of the test itemfor 24 hours.
1 animal was treated topically with concentrations of 50% (emulsified with vaseline)and 100% (undiluted) of the test itemfor 48 hours.
1 animal was treated topically with concentrations of 12.5%, 25% (two application sites) and 50% of the test item (dissolved in physiological saline 0.9% NaCl)for 24 hours.
1 animal was treated topically with concentrations of 12.5%, 25% (two application sites) and 50% of the test item (dissolved in physiological saline 0.9% NaCl)for 48 hours.
Based on the results of this preliminary test, a concentration of 1% was chosen for the intradermal application of the main test and a concentration
of 50% was selected for the dermal induction. These concentrations caused slight signs of irritation, without leading to systemic effects.
A concentration of 12.5% was found to be the highest dose which did not cause any signs of irritation after a topical treatment over a period
of 24 hours and therefore was chosen for the challenge application in the main test.
Main Test
Signs of irritation during the induction:
Intradermal Induction I (24-hour reading):
Injection site 1: erythema grade 1 in 5/5 control and 10/10 test animals, oedema grade 1 in 5/5 control and 10/10 test animals.
Injection site 2: erythema grade 1, oedema grade 1 and eschar in 10/10 test animals.
Injection site 3:erythema grade 1 in 5/5 control and 10/10 test animals, oedema grade 1 in 5/5 control and 10/10 test animals.
Intradermal Induction I (48-hour reading):
Injection site 1:erythema grade 1 in 5/5 control and 10/10 test animals, oedema grade 1 in 5/5 control and 10/10 test animals.
Injection site 2: erythema grade 1, oedema grade 1 and eschar in 10/10 test animals.
Injection site 3: erythema grade 1 in 5/5 control and 10/10 test animals, oedema grade 1 in 5/5 control and 10/10 test animals.
Dermal Induction II (48-hour exposure, occlusive):
Immediately after
removing the patch: no signs of irritation in any of the test or control animals.
24 hours after
removing the patch: no signs of irritation in any of the test or control animals.
Challenge Exposure (24-hour exposure, occlusive):
Neither erythema nor oedema was observed in any animal at any time of observation.
There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
Table: Challenge Exposure
Challenge Concentrations of Test Substance: 12.5% |
||
|
Number of Animals Showing Skin Reactions after |
|
24 hours |
48 hours |
|
Test Group |
0 |
0 |
Negative-Control Group |
0 |
0 |
Body Weight Development
The body weight development was within the biological range for all animals compared to historical data.
All animals of both groups survived throughout the test period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to determine the sensitizing potential of the test substance read across to two OECD 406 Magunsson &Kligman test in guinea pigs with analogue substances were assessed. Under the experimental conditions, both the analogue test substances i.e.salt of an alkenyl succinic acid derivative (CAS no. n.a.) and Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts Variante TEA/Na salt (EINECS no. 800 -765 -8) do not induce delayed contact hypersensitivity in guinea pigs.
Rationale for the read-across: Refer to IUCLID Chapter 13 "Assessment reports", Read across justification. Based on results of the Magnusson & Kligman test in guinea pigs (acc. to OECD 406) with two analogue substances it is concluded that the test substance registered has no skin sensitizing properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, both the analogue test substances, i.e.salt of an alkenyl succinic acid derivative(CAS no. n.a.) and Pentapropylensuccinic anhydride, reaction products with ethanolamine, sodium and triethanolamine salts Variante TEA/Na salt (EINECS no. 800 -765 -8) do not induce delayed contact hypersensitivity in guinea pigs. Read across is justified as for the analogue substances as well as for the registered substance identical/similar metabolites are presumed after enzymatic hydrolysis.
Thus, it is considered, that no classification is warranted for the registration substance according to the OECD GHS criteria.
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