Alcohols, C20-22, reaction products with phosphorus oxide (P2O5)

Endpoint summary

Description of key information

- Skin irritation: not irritating

- Eye irritation: irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-04-03 to 2000-06-23

Reliability:

1 (reliable without restriction)

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:

3 female albinos rabbits, numerated A3213 to A3215 of new-zealand strain, originating from the Elevage de Gérome (Quartier Labaste – 40260 Linxe) were kept during a 7-day acclimatisation period. During the test, the animals weighted between 2.11kg and 2.41kg.
The animals were kept in individual boxes installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 39% and 54%

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g/animal

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, 24, 48 and 72 hours after patch removal

Number of animals:

3

Details on study design:

- 3 rabbits, each animal was its own contol
- topic application for 4 hours under occlusive patch on the right flank for the test produt and on the left flank for the vehicle (distilled water)
- skin reactions (erythema and oedema) were scored 1 hour, 24, 48 and 72 hours after removal of the patch

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

24 hours after removal of the patch: 0/3 animals with skin reaction
48 hours after removal of the patch: 0/3 animals with skin reaction
72 hours after removal of the patch: 0/3 animals with skin reaction
Total sum of registerd scores = 0
Primary skin irritation (PSi) =0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained, in these experimental conditions, enabled to conclude that the test product, according to the scales of interpretation retained :
- is non irritant to skin (PSi =0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,
- and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548 and 93/21.

Executive summary:

The test product was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits, according to an experimental protocol established from the O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of the E.E.C. directive n° 92/69 dated December 29th,1992. No cutaneous reactions (erythema and oedema) were observed in any animal whatever the examination time. The results obtained, in these experimental conditions, enabled to conclude that the test product, according to the scales of interpretation retained :

- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,

- and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548 and 93/21.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-04-19 to 2000-06-23

Reliability:

1 (reliable without restriction)

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:

Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste– F40260 Linxe). They were kept during a minimal 6-day acclimatisation period. During the test, the animals weighed between 1.95 kg and 2.45 kg.

The environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 39% and 54%

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

3

Details on study design:

- 3 rabbits
- 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment. Evaluation of chemosis, redness of the conjunctivae, iris lesion and cornea opacity.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

11.3

Max. score:

12

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: D1

Score:

21.3

Max. score:

22

Reversibility:

fully reversible within: the 7th and the 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: (D2) Day 2

Score:

10.7

Max. score:

13

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: (D3) Day 3

Score:

5.7

Max. score:

9

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: D4

Score:

4.3

Max. score:

7

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: D5

Score:

2

Max. score:

2

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: D6

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: D7

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: the 4th and 6th day of the test.

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible within: the 4th and 6th day of the test.

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: the 4th and 6th day of the test.

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

fully reversible within: the 7th and 8th day of the test.

Remarks on result:

probability of moderate irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

2

Reversibility:

fully reversible within: the 7th and the 8th day of the test

Remarks on result:

probability of moderate irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: the 7th and the 8th day of the test

Remarks on result:

probability of moderate irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: the 7th and the 8th day of the test

Remarks on result:

probability of moderate irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: the 7th and the 8th day of the test

Remarks on result:

probability of moderate irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: the 7th and the 8th day of the test

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility:
- slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test,
- slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.
Average irritation index:
D0 1 hour : 11.3
D1: 21.3
D2: 10.7
D3: 5.7
D4: 4.3
D5: 2.0
D6: 1.3
D7: 0.0

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item:
- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, need not to be classified, according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
- need to be classified Eye Irritation 2; H319 according to the CLP regulation n°1272/2008/EC

Executive summary:

The test substance was instilled, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated February 24th 1987 and the test method B.5 of the directive 92/69 dated December 29th 1992.

The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility: - slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test, - slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance:

- is moderately irritant for the eye (Max. O.I = 21.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.

- and, need not to be classified, according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.

- need to be classified Eye Irritation 2; H319 according to the CLP regulation n°1272/2008/EC (2 of 3 animals had a corneal opacity score >= 1, fully reversible in 21 days)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin and eye irritation were tested in rabbits. Each key study is quoted as reliability 1 according to Klimisch criteria (OECD studies and performed in accordance with GLP).

Skin irritation/corrosion:

The test product was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits, according to an experimental protocol established from the O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of the E.E.C. directive n° 92/69 dated December 29th,1992. No cutaneous reactions (erythema and oedema) were observed in any animal whatever the examination time. The results obtained, in these experimental conditions, enabled to conclude that the test product, according to the scales of interpretation retained is non irritant to the skin (PSi = 0).

Eye irritation:

The test substance was instilled, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated February 24th 1987 and the test method B.5 of the directive 92/69 dated December 29th 1992.

The ocular reactions observed, at the level of each treated eyes were slight to moderate with a rapid reversibility: - slight to moderate conjunctivae reaction (enanthema, lachrymation and chemosis) recorded 1 hour after the test product instillation and totally reversible between the 7th and 8th day of the test, - slight to moderate corneal reaction were noted for 2 animals 24 hours after the test product instillation and totally reversible between the 4th and the 6th day of the test.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance is considered as irritant to the eye and need to be classified Eye Irritation 2; H319 according to the CLP regulation n°1272/2008/EC (2 of 3 animals had a corneal opacity score >= 1, fully reversible in 21 days).

Justification for classification or non-classification

Based on the classification criteria of EU GHS, C20/22 alkyl phosphate is not considered as irritant to the skin, but needs to be classified as Eye Irritation 2; H319.