Registration Dossier

Administrative data

Description of key information

One skin sensitisation study is available. Hartley guinea pigs were used as the test species. The study was conducted using the Guinea Pig maximisation test using the Magnusson-Kligmann method.

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:
18 June 1985 - 9 August 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Twenty animals per test group were injected intradermally on day 0 with different concentrations or the test material in physiological saline. Each animal also received two intradermal injections of 50% v/v Freund's complete adjuvant (FCA) in distilled water and two injections of the test or control material in the FCA formulation. On day 7 or 8, the test animals in the groups received different concentrations of the test material in petrolatum topically under elastoplast bandage wrappings for 48 hours. On day 19 or 21, the respective induced test animals were challenged with the three concentrations of the test material in petrolatum plus undiluted petrolatum topically under Elastoplast bandage wrappings for 24 hours. On the day after removal of the topical application, the sites were depilated. Later that day and again the next day, the sites were graded for erythema responses (24 and 48 hour responses).
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An older guinea pig maximisation test is available that is acceptable for classification purposes; further testing by the LLNA method is not considered necessary
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl Acetate
- Physical state: Liquid with strong odour
- Storage condition of test material: refrigeration in covered amber glass bottles
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lab Animal Supply Company
- Age at study initiation: not stated
- Weight at study initiation: 300 - 400 g
- Housing: singly in wire mesh suspension cages
- Diet (e.g. ad libitum): Purina Guinea Pig Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

IN-LIFE DATES: From: 9 July 1985 To: 2 August 1985
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
Primary irritation: 100, 50, 25, 10, 5, 2.5, 1.25 and 0.625% v/v
Induction - intradermal:
- Site 1: 50% v/v FCA in distilled water (all groups)
- Site 2: 10% test substance in saline (tes group), undiluted saline (control group)
- Site 3: 10% test substacne in FCA (test group), 50% FCA in saline (control group
Induction - Topical: 30% v/v test substance in petrolatum to all sites
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
Primary irritation: 100, 50, 25, 10, 5, 2.5, 1.25 and 0.625% v/v
Induction - intradermal:
- Site 1: 50% v/v FCA in distilled water (all groups)
- Site 2: 10% test substance in saline (tes group), undiluted saline (control group)
- Site 3: 10% test substacne in FCA (test group), 50% FCA in saline (control group
Induction - Topical: 30% v/v test substance in petrolatum to all sites
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Primary irritation

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: -
- Test groups:
Induction - intradermal:
Site 1: 50% v/v FCA in distilled water (all groups)
Site 2: 10% test substance in saline (tes group)
Site 3: 10% test substacne in FCA (test group)
Induction - Topical: 30% v/v test substance in petrolatum to all sites
- Control group: 1
Induction - intradermal:
Site 1: 50% v/v FCA in distilled water (all groups)
Site 2: undiluted saline (control group)
Site 3: 50% FCA in saline (control group)
Induction - Topical: Undiluted petrolatum to all sites
- Site: 3 sites each side of the midline
- Frequency of applications: Once for each type of induction
- Duration: One intradermal, the other topical for 48 hours
- Concentrations: intradermal 30%, topical 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 19 or 21
- Exposure period: 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: the maximum non-irritating concentration and two lower concentrations
- Evaluation (hr after challenge): 4-8 hours after patch removal (24-hour reading) and the next day (28-hour reading)
Challenge controls:
12 animals, male/female, Maximum non-irritating concentration
Positive control substance(s):
no
Concentration:
N/A
No. of animals per dose:
N/A
Details on study design:
N/A
Statistics:
N/A
Positive control results:
N/A
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1% v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3% v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10% v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10% v/v
No. with + reactions:
3
Total no. in group:
12
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: No data.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Undiluted vehicle
Dose level:
0
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Undiluted vehicle. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1% v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
3% v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3% v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%v/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%v/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10% v/v
No. with + reactions:
3
Total no. in group:
12
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% v/v. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: No data.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Undiluted vehicle
Dose level:
0
No. with + reactions:
8
Total no. in group:
20
Clinical observations:
No data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Undiluted vehicle. Dose level: 0. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: No data.

Group

Concentration

Number of responders / Number treated

Mean severity (24 hours)

Mean severity (48 hours)

Class of response

Test

10

0/20

0.5

0.5

Weak

Test

3

0/20

0.5

0.6

Weak

Test

1

0/20

0.5

0.6

Weak

Control

10

3/12

0.5

0.5

Mild

Control (vehicle)

Undiluted

8/20

0.5

0.8

Moderate

Interpretation of results:
GHS criteria not met
Conclusions:
The responses to the test substance were rated as weak. Benzyl acetate is not considered to be sensitising. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

Twenty animals per test group were injected intradermally on day 0 with different concentrations or the test material in physiological saline. Each animal also received two intradermal injections of 50% v/v Freund's complete adjuvant (FCA) in distilled water and two injections of the test or control material in the FCA formulation. On day 7 or 8, the test animals in the groups received different concentrations of the test material in petrolatum topically under elastoplast bandage wrappings for 48 hours. On day 19 or 21, the respective induced test animals were challenged with the three concentrations of the test material in petrolatum plus undiluted petrolatum topically under Elastoplast bandage wrappings for 24 hours. On the day after removal of the topical application, the sites were depilated. Later that day and again the next day, the sites were graded for erythema responses (24 and 48 hour responses).

According to Regulation (EC) No. 1272/2008, no classification is warranted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a study conducted by Kreuzmann (1985), the test substance, benzyl acetate was examined for its ability to cause sensitisation. Twenty Hartley guinea pigs per test group were injected intradermally on day 0 with different concentrations or the test material in physiological saline. Each animal also receeved two intradermal injections of 50% v/v Freund's complete adjuvant (FCA) in distilled water and two injections of the test or control material in the FCA formulation. On day 7 or 8, the test animals in the groups recieved different concentrations of the test material in petrolatum topically under elastoplast bandage wrappings for 48 hours. On day 19 or 21, induced test animals were challenged with the three concentrations of the test material in petrolatum plus undiluted petrolatum topically under Elastoplast bandage wrappings for 24 hours. On the day after removal of the topical application, the sites were depilated. Later that day and again the next day, the sites were graded for erythema responses (24 and 48 hour responses).

According to Regulation (EC) No. 1272/2008, no classification is warranted.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin Sensitisation:

Based on the results of the available study, the test susbtance does not require classification according to Regulation EC No. 1272/2008.