Alcohols, C6-8, ethoxylated

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

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 LLNA test is not suitable for the test item since it possess surfactant properties. Therefore, testing according to OECD TG 406 was performed.

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. 0930), 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 (preliminary test: lot no. 190711, main study: lot no. 110811)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions

Route:

intradermal and epicutaneous

Vehicle:

other: physiological saline 0.9% NaCl

Concentration / amount:

For the intradermal injection (induction - first stage), 0.075 g of the test item were dissolved in physiological saline 0.9% NaCl to gain a final
volume of 5mL of a 1.5% solution (w/v).
For the topical application (induction – second stage) the test item was applied directly at a 100% concentration.
For the topical application (challenge) the test item was applied directly at a 100% concentration.

Route:

epicutaneous, occlusive

Vehicle:

other: physiological saline 0.9% NaCl

Concentration / amount:

For the intradermal injection (induction - first stage), 0.075 g of the test item were dissolved in physiological saline 0.9% NaCl to gain a final
volume of 5mL of a 1.5% solution (w/v).
For the topical application (induction – second stage) the test item was applied directly at a 100% concentration.
For the topical application (challenge) the test item was applied directly at a 100% concentration.

No. of animals per dose:

10 test animals and 5 control animals

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 1.5% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 1.5% 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 physiological saline 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 applied at a concentration of 100%. 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: Topical Application
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 applied at a concentration of 100%. A patch, loaded with 0.5 mL of the prepared test item was applied to the
left flank of the animals and a patch 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 21 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.

Challenge controls:

patch

Positive control substance(s):

not required

Remarks:

performed periodically every 6 months

Positive control results:

Positive-control substance: mercaptobenzothiazole, purity 98%,
Fluka Chemica, Lot No. 440769/1, expiry date: 20/01/2014
Concentrations: 2% induction I phase, 25% induction II phase, 15% challenge
The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (15% in vaseline) was 100%, confirming the
reliability of the test system.

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Remarks on result:

not measured/tested

Reading:

1st reading

Hours after challenge:

48

Group:

positive control

Remarks on result:

not measured/tested

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100% physiological saline

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% physiological saline. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

100% physiological saline

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% physiological saline. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study it can be stated that the test item Alcohols, C6-8-alkyl-(even, linear), ethoxylated (< 2.5 EO) caused no reactions identified as sensitisation at the tested concentration. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 2001/59/EC) labelling is not necessary.
According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System)the test item Alcohols, C6-8-alkyl-(even, linear), ethoxylated (< 2.5 EO) has no obligatory labelling requirement for skin sensitisation and is unclassified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The sensitization potential of the submission substance was investigated in an guideline conform maximization test in male guinea pigs according to magnusson and Kligman. 10 test and 5 control animals were used. Based on the results of sighting tests a test substance concentration of 1.5% (v/v) for the intradermal induction was used. For topical sensitization as well as the dermal challenge phase the 100% (v/v) undiluted test material was selected for the treatments. Under the conditions of this test, the submission substance produced a 0% (0/10) sensitization rate.

Migrated from Short description of key information:
A guideline conform maximization test according to Magnusson and Kligman (OECD TG 406) in guiena pigs with the submission substance showed no evidence for skin sensitising properties.

Justification for selection of skin sensitisation endpoint:
Guideline study according to GLP with Klimisch rating 1

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:
The submission substance is not classified for the endpoint respiratory sensitization because no indications from the toxicological profile, especially from skin sensitization exist to anticipate a respective effect on the respiratory tract.

Justification for classification or non-classification

From a guideline and GLP compliant study according OECD 406, no skin sensitizing properties are attributable to the submission substance. Thus, no classification according to the criteria of the EU Dangerous Substance Directive (67/548/EEC) or the EU Classification, Labelling and Packaging Regulation (1272/2008/EC) is required.

For respiratory sensitization it can reasonably be deduced that the submission substance does not exert respiratory tract sensitization and therefore no classification is required.