Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19/12/2016 - 24/03/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The registration substance is a surfactant.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
The test material corresponded to the approximately 45% of the registration substance.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd., No.93, Solur, Thally Road, Anekal, Bengaluru - 562106, India

- Age at study initiation: 15 to 17 weeks at intra-dermal induction
- Weight at study initiation: Males : 396.74 to 489.13 g, Females : 410.05 to 474.02 g

- Housing: Animals were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm)
- Diet (e.g. ad libitum): Guinea pig feed manufactured by Pranav agro Industries Ltd, Pune, Maharashtra
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in ‘Aquaguard’ on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India
- Acclimation period: Start : 28 January 2017 End : 04 February 2017


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 48 to 67%
- Air changes (per hr): 12 to 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 28 January 2017 To: 01 March 2017

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Remarks:
The test material corresponds ca 45% of the registration substance in water
Concentration / amount:
Site 1: 0.1 mL of 50% Freund's Adjuvant in vehicle
Site 2: 0.1 mL of the test item in vehicle (25% w/v)
Site 3: 0.1 mL of 1:1 mixture of test item in vehicle (50% w/v) and Freund's Adjuvant in vehicle (50%)
Day(s)/duration:
On day 1
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 mL of test item
Day(s)/duration:
On day 8
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Day(s)/duration:
On day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 (5 male and 5 female) for control group
20 (10 male and 10 female) for treatment group
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

Positive control results:
Skin sensitization rate of 60% at 24h reading and 50% at 48h reading

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effect
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effect
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

TABLE 1.             Summaryof Skin Reactions

INDUCTION

 

Group

Observation

Concentration (%w/v)

Application site

INDUCTION PERIOD

Time (hours)

Injection

site

Skin reaction scores and response*

Erythema

Edema

G1

(Vehicle Control)

Intradermal

Induction

‘0’

Shoulder region

24

1

2

3

10**/10

0/10

10**/10

10Ψ/10

0/10

10Ψ/10

48

1

2

3

10**/10

0/10

10**/10

10Ψ/10

0/10

10Ψ/10

Topical application

‘0’

Shoulder region

1@

 

NA

0/10

0/10

24@

 

NA

0/10

0/10

 

 

 

 

G2 (Treatment)

Intradermal

Induction

25

Shoulder region

24

1

2

3

20**/20

20**/20

20**/20

20Ψ/20

19Ψ/20

20Ψ/20

48

1

2

3

20**/20

16**/20

20**/20

20Ψ/20

0Ψ/20

20Ψ/20

Topical application

0.5 mL of undiluted test item

Shoulder region

1@

NA

0/20

0/20

24@

NA

0/20

0/20

@ : Observation post removal of test patch;                 NA: Not Applicable

*  : Represents the number of animals showing skin reactions out of the total number

      of animals in each group

** : Skin reaction score of 1-very slight erythema (barely perceptible)

Ψ : Skin reaction score of 1-very slight edema (barely perceptible)

0  : No erythema / No edema – correspondingly


 TABLE 1 contd. Summary of Skin Reactions

 

CHALLENGE

Group

Concentration (%w/v)

Application site

CHALLENGE PERIOD

Time (hours)

Skin reaction

Response

Sensitization rate (%)

G1

(Vehicle Control)

 

0.5 mL of undiluted test item

Left flank

24

 

0*/10

0

48

 

0*/10

0

 

G2 (Treatment)

 

0.5 mL of undiluted test item

Left flank

24

 

0*/20

0

48

 

0*/20

0

 

*

:

Represents the number of animals showing sensitisation response out of the total number of animals challenged in each group

 


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitization property of the registration substance was treated according to the Guideline OECD 406. Based on the result obtained no classification is warranted.
Executive summary:

The skin sensitization property of the registration substance was investigated according to the Guideline OECD 406 in guinea pigs. The test substance corresponded to ca 45% of registration substance in water. For the intradermal and the topical induction the animals were treated at concentration of 25% and 100% of test material respectively, and for the challenge the animals were treated at concentration of 100 % of test material. None of the treated animals responded. The registration substance is not skin sensitizing.