Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
FAT 40879/B is considered not a potential skin sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Starting Date 08 March 2021 Experimental Completion Date 07 April 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- adopted 25th June 2018
- Deviations:
- yes
- Remarks:
- Study Plan Amendment No. 1: Dose Selection for Main Study. Study Plan Amendment No. 2: Correction in test item storage condition
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Specific details on test material used for the study:
- Identification: FAT 40879/B TE
Appearance: Dark red powder
Purity: 80.5 % all colored organic constituents; main constituent 66.9 %
Batch No.: BOP 05-20 (MC -0065114700/800 1:1)
Manufacture Date June 26, 2020
Expiry Date: September 08, 2025
Storage Conditions: Freezer (-15 °C to -20 °C) - Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
Animal Breeding RCC Laboratories India Private Limited, Genome Valley, Turkapally, Shameerpet (Mandal), Ranga Reddy District, Hyderabad - 500 078 India.
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]: Yes
- Age at study initiation: Pretest: Approximately 9 - 11 Weeks; Main Study- Approximately 9 - 11 Weeks
- Weight at study initiation: Pretest- Females: 18.93 g to 20.32 g; Main Study- Females: 20.69 g to 22.78 g
- Housing: Individually in Polycarbonate cages
- Diet: Rat/Mice Pelleted Feed (Batch Number 037) from VRK Nutritional Solutions was provided ad libitum
- Water: UV purified water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 to 23.7
- Humidity (%): 53 to 62
- Air changes (per hr): The animal room was air-conditioned with adequate (above 10) air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25, 50, 100 %
- No. of animals per dose:
- 5 female per dose
- Positive control substance(s):
- eugenol (CAS No 97-53-0)
- Statistics:
- No statistical analysis was performed.
- Positive control results:
- Stimulation Index (SI) of Positive Control was 4.574 and thus confirmed the validity of the test system
- Parameter:
- SI
- Value:
- 1.068
- Test group / Remarks:
- Low dose 10 %
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- Low mid dose 15 %
- Parameter:
- SI
- Value:
- 1.212
- Test group / Remarks:
- High mid dose 20 %
- Parameter:
- SI
- Value:
- 1.171
- Test group / Remarks:
- High dose 25 %
- Cellular proliferation data / Observations:
- A BrdU ELISA measurement with cell suspension of Auricular lymph nodes resulted in mean stimulation indexes of 1.068, 1.110, 1.212 and 1.171 at concentrations of 10 %, 25 %, 50 % and 100 %, respectively. Stimulation Index (SI) of Positive Control was 4.574 and thus confirmed the validity of the test system.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40879/B is considered not a potential skin sensitizer.
- Executive summary:
In a GLP-compliant study carried out according to OECD guideline 442B, thirty healthy female animals were allocated into six groups, each group consist of five female BALB/c mice. Animals in group 1 (G1) was applied to both ears with vehicle alone (Acetone+Olive oil) in 4:1 ratio and served as Vehicle Control (VC). FAT 40879/B TE was applied to both ears at the concentrations of 10 % (Low), 25 % (Low Mid), 50 % (High Mid) and 100 % (High) for dose groups G2, G3, G4 and G5, respectively.
In addition, animals in group 6 (G6) (Positive Control) was applied to both ears with reference item Eugenol (25 %). Test item and reference item was formulated in Acetone+Olive oil (4:1) to get the required concentrations. Dorsum of both ears of the animal was used as treatment site. The animals were observed for mortality/viability twice daily during the acclimatization period, treatment and observation days and once on day of receipt, holidays and sacrifice. Body weights were recorded on test Day 1 (prior to test item administration) and Day 6. The animals were observed for clinical signs once daily during the acclimatization period, twice daily approximately at 1st and 4th hours after test item administration on test Day 1- 3 and Day 5 and once on Day 4 and Day 6. The skin reactions were recorded on day 1-6, ear thickness was measured on Day 1, 3, and 6. All animals were necropsied and examined macroscopically at the end of observation period. The auricular lymph nodes were collected from both ears and analyzed with BrdU ELISA. All animals appeared normal throughout the acclimatization as well as study observation period. The body weight of the animals was within the normal range of variability commonly recorded for this species, strain and age. No erythema was observed prior to administration period. No erythema was found in Vehicle Control group and the animals treated with dose concentrations of Low, Low Mid, High Mid and High dose groups from Day 1 to Day 6 whereas, in Positive Control group all the animals showed well defined erythema on both the ears from Day 2 to Day 6. Ear thickness measurement in treated group animals was comparable with Vehicle Control group whereas, ear thickness was slightly increased in Positive Control group from Day 2 to Day 6 when compared with Vehicle Control group. No abnormalities were observed externally and internally in Vehicle Control, Low, Low Mid, High Mid and High dose group animals at necropsy. Ears (bilateral) - reddened, slightly was observed externally and auricular lymph node (bilateral) - enlarged, slightly was observed internally in Positive Control group at terminal sacrifice.BrdU ELISA measurement with Positive Control animal cell suspension of auricular lymph nodes revealed Stimulation Index (SI) value was 4.574. As the SI was greater than 1.6, sensitivity and validity of the test system was confirmed. BrdU ELISA measurement with treated groups (G2 to G5) resulted in 1.068 to 1.212. As the Stimulation Index was less than 1.6, FAT 40879/B TE is considered not a potential skin sensitizer.
Reference
SKIN REACTIONS
Reaction Scores |
||||||||||
Group |
Dose |
Animal Number |
Sex |
Site of Application |
Observation Day |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||
1 |
0% (VC) |
01 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
02 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
03 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
04 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
05 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
2 |
10% (L) |
06 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
07 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
08 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
09 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
10 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Key: VC- Vehicle Control, L-Low, % - Percent
SKIN REACTIONS (Contd.)
Reaction Score |
||||||||||
Group |
Dose |
Animal Number |
Sex |
Site of Application |
Observation Day |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||
3 |
25% (LM) |
11 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
12 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
13 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
14 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
15 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
4 |
50% (HM) |
16 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
17 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
18 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
19 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
20 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Key: LM-Low Mid, HM-High Mid, % - Percent
SKIN REACTIONS (Contd.)
Reaction Scores |
||||||||||
Group |
Dose |
Animal Number |
Sex |
Site of Application |
Observation Day |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||
5 |
100% (H) |
21 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
22 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
23 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
24 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
25 |
Female |
Right Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||
Left Ear |
0 |
0 |
0 |
0 |
0 |
0 |
||||
6 |
25% (PC) |
26 |
Female |
Right Ear |
0 |
2 |
2 |
2 |
2 |
2 |
Left Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||||
27 |
Female |
Right Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||
Left Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||||
28 |
Female |
Right Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||
Left Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||||
29 |
Female |
Right Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||
Left Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||||
30 |
Female |
Right Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||
Left Ear |
0 |
2 |
2 |
2 |
2 |
2 |
||||
Key: H-High; PC-Positive Control, % - Percent
1.1 EAR THICKNESS MEASUREMENTS ON DAY 1
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
1 |
0% (VC) |
01 |
Female |
Right Ear |
0.278 |
0.280 |
0.291 ± 0.0086 |
Left Ear |
0.281 |
||||||
02 |
Female |
Right Ear |
0.286 |
0.287 |
|||
Left Ear |
0.288 |
||||||
03 |
Female |
Right Ear |
0.291 |
0.293 |
|||
Left Ear |
0.294 |
||||||
04 |
Female |
Right Ear |
0.302 |
0.303 |
|||
Left Ear |
0.304 |
||||||
05 |
Female |
Right Ear |
0.294 |
0.293 |
|||
Left Ear |
0.291 |
||||||
2 |
10% (L) |
06 |
Female |
Right Ear |
0.279 |
0.281 |
0.281 ± 0.0112 |
Left Ear |
0.282 |
||||||
07 |
Female |
Right Ear |
0.301 |
0.302 |
|||
Left Ear |
0.303 |
||||||
08 |
Female |
Right Ear |
0.298 |
0.299 |
|||
Left Ear |
0.299 |
||||||
09 |
Female |
Right Ear |
0.276 |
0.277 |
|||
Left Ear |
0.278 |
||||||
10 |
Female |
Right Ear |
0.294 |
0.295 |
|||
Left Ear |
0.296 |
Key: mm-Millimeter; VC- Vehicle Control, L-Low, % - Percent
13.4 EAR THICKNESS MEASUREMENTS ON DAY 1 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
3 |
25% (LM) |
11 |
Female |
Right Ear |
0.303 |
0.304 |
0.297 ± 0.0074 |
Left Ear |
0.305 |
||||||
12 |
Female |
Right Ear |
0.285 |
0.286 |
|||
Left Ear |
0.287 |
||||||
13 |
Female |
Right Ear |
0.293 |
0.294 |
|||
Left Ear |
0.295 |
||||||
14 |
Female |
Right Ear |
0.297 |
0.298 |
|||
Left Ear |
0.299 |
||||||
15 |
Female |
Right Ear |
0.304 |
0.305 |
|||
Left Ear |
0.306 |
||||||
4 |
50% (HM) |
16 |
Female |
Right Ear |
0.292 |
0.293 |
0.295 ± 0.0061 |
Left Ear |
0.293 |
||||||
17 |
Female |
Right Ear |
0.304 |
0.305 |
|||
Left Ear |
0.306 |
||||||
18 |
Female |
Right Ear |
0.288 |
0.290 |
|||
Left Ear |
0.291 |
||||||
19 |
Female |
Right Ear |
0.291 |
0.292 |
|||
Left Ear |
0.293 |
||||||
20 |
Female |
Right Ear |
0.295 |
0.297 |
|||
Left Ear |
0.298 |
Key: mm-Millimeter, LM-Low Mid, HM-High Mid, % - Percent
13.4 EAR THICKNESS MEASUREMENTS ON DAY 1 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
5 |
100% (H) |
21 |
Female |
Right Ear |
0.306 |
0.308 |
0.302 ± 0.0065 |
Left Ear |
0.309 |
||||||
22 |
Female |
Right Ear |
0.301 |
0.302 |
|||
Left Ear |
0.303 |
||||||
23 |
Female |
Right Ear |
0305 |
0.304 |
|||
Left Ear |
0.302 |
||||||
24 |
Female |
Right Ear |
0.289 |
0.291 |
|||
Left Ear |
0.292 |
||||||
25 |
Female |
Right Ear |
0.303 |
0.304 |
|||
Left Ear |
0.305 |
||||||
6 |
25% (PC) |
26 |
Female |
Right Ear |
0.292 |
0.293 |
0.299 ± 0.0058 |
Left Ear |
0.294 |
||||||
27 |
Female |
Right Ear |
0.304 |
0.306 |
|||
Left Ear |
0.307 |
||||||
28 |
Female |
Right Ear |
0.299 |
0300 |
|||
Left Ear |
0.301 |
||||||
29 |
Female |
Right Ear |
0.294 |
0.293 |
|||
Left Ear |
0.292 |
||||||
30 |
Female |
Right Ear |
0.302 |
0.304 |
|||
Left Ear |
0.305 |
Key: mm-Millimeter, H-High, PC-Positive Control, % - Percent
1.2 EAR THICKNESS MEASUREMENTS ON DAY 3
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
1 |
0% (VC) |
01 |
Female |
Right Ear |
0.280 |
0.282 |
0.293 ± 0.0088 |
Left Ear |
0283 |
||||||
02 |
Female |
Right Ear |
0.288 |
0.290 |
|||
Left Ear |
0.291 |
||||||
03 |
Female |
Right Ear |
0.293 |
0.295 |
|||
Left Ear |
0.297 |
||||||
04 |
Female |
Right Ear |
0.305 |
0.306 |
|||
Left Ear |
0.306 |
||||||
05 |
Female |
Right Ear |
0.296 |
0.295 |
|||
Left Ear |
0.294 |
||||||
2 |
10% (L) |
06 |
Female |
Right Ear |
0.282 |
0.283 |
0.283 ± 0.0112 |
Left Ear |
0.284 |
||||||
07 |
Female |
Right Ear |
0.303 |
0.305 |
|||
Left Ear |
0.306 |
||||||
08 |
Female |
Right Ear |
0.301 |
0.302 |
|||
Left Ear |
0.302 |
||||||
09 |
Female |
Right Ear |
0.278 |
0.280 |
|||
Left Ear |
0.281 |
||||||
10 |
Female |
Right Ear |
0.296 |
0.297 |
|||
Left Ear |
0.298 |
Key: mm-Millimeter; VC- Vehicle Control, L-Low, % - Percent
13.5 EAR THICKNESS MEASUREMENTS ON DAY 3 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
3 |
25% (LM) |
11 |
Female |
Right Ear |
0.306 |
0.307 |
0.300 ± 0.0074 |
Left Ear |
0.307 |
||||||
12 |
Female |
Right Ear |
0.287 |
0.288 |
|||
Left Ear |
0.289 |
||||||
13 |
Female |
Right Ear |
0.295 |
0.297 |
|||
Left Ear |
0.298 |
||||||
14 |
Female |
Right Ear |
0.299 |
0.301 |
|||
Left Ear |
0.302 |
||||||
15 |
Female |
Right Ear |
0.306 |
0.307 |
|||
Left Ear |
0.307 |
||||||
4 |
50% (HM) |
16 |
Female |
Right Ear |
0.295 |
0.295 |
0.298 ± 0.0059 |
Left Ear |
0.294 |
||||||
17 |
Female |
Right Ear |
0.306 |
0.307 |
|||
Left Ear |
0.308 |
||||||
18 |
Female |
Right Ear |
0.291 |
0.292 |
|||
Left Ear |
0.293 |
||||||
19 |
Female |
Right Ear |
0.294 |
0.295 |
|||
Left Ear |
0.296 |
||||||
20 |
Female |
Right Ear |
0.297 |
0.299 |
|||
Left Ear |
0.301 |
Key: mm-Millimeter, LM-Low Mid, HM-High Mid, % - Percent
13.5 EAR THICKNESS MEASUREMENTS ON DAY 3 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
5 |
100%(H) |
21 |
Female |
Right Ear |
0.308 |
0.310 |
0.304 ± 0.0064 |
Left Ear |
0.311 |
||||||
22 |
Female |
Right Ear |
0.304 |
0305 |
|||
Left Ear |
0.305 |
||||||
23 |
Female |
Right Ear |
0.307 |
0.307 |
|||
Left Ear |
0.306 |
||||||
24 |
Female |
Right Ear |
0.292 |
0.293 |
|||
Left Ear |
0.294 |
||||||
25 |
Female |
Right Ear |
0.305 |
0.306 |
|||
Left Ear |
0.307 |
||||||
6 |
25% (PC) |
26 |
Female |
Right Ear |
0.489 |
0.491 |
0.504 ± 0.0156 |
Left Ear |
0.493 |
||||||
27 |
Female |
Right Ear |
0.505 |
0.507 |
|||
Left Ear |
0.508 |
||||||
28 |
Female |
Right Ear |
0.509 |
0.510 |
|||
Left Ear |
0.511 |
||||||
29 |
Female |
Right Ear |
0.486 |
0.488 |
|||
Left Ear |
0.489 |
||||||
30 |
Female |
Right Ear |
0.525 |
0.526 |
|||
Left Ear |
0.527 |
Key: mm-Millimeter, H-High, PC-Positive Control, % - Percent
1.3 EAR THICKNESS MEASUREMENTS ON DAY 6
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
1 |
0% (VC) |
01 |
Female |
Right Ear |
0.282 |
0.283 |
0.295 ± 0.0091 |
Left Ear |
0.284 |
||||||
02 |
Female |
Right Ear |
0.290 |
0.292 |
|||
Left Ear |
0.293 |
||||||
03 |
Female |
Right Ear |
0.296 |
0.297 |
|||
Left Ear |
0.298 |
||||||
04 |
Female |
Right Ear |
0.307 |
0.308 |
|||
Left Ear |
0.309 |
||||||
05 |
Female |
Right Ear |
0.298 |
0.297 |
|||
Left Ear |
0.296 |
||||||
2 |
10% (L) |
06 |
Female |
Right Ear |
0.285 |
0.286 |
0.286 ± 0.0111 |
Left Ear |
0.286 |
||||||
07 |
Female |
Right Ear |
0.305 |
0.306 |
|||
Left Ear |
0.307 |
||||||
08 |
Female |
Right Ear |
0.303 |
0.304 |
|||
Left Ear |
0.304 |
||||||
09 |
Female |
Right Ear |
0279 |
0.281 |
|||
Left Ear |
0.283 |
||||||
10 |
Female |
Right Ear |
0.298 |
0.299 |
|||
Left Ear |
0.300 |
Key: mm-Millimeter; VC- Vehicle Control, L-Low, % - Percent
13.6 EAR THICKNESS MEASUREMENTS ON DAY 6 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
3 |
25% (LM) |
11 |
Female |
Right Ear |
0.308 |
0.309 |
0.301 ± 0.0070 |
Left Ear |
0.309 |
||||||
12 |
Female |
Right Ear |
0.289 |
0.290 |
|||
Left Ear |
0.291 |
||||||
13 |
Female |
Right Ear |
0.297 |
0.299 |
|||
Left Ear |
0.300 |
||||||
14 |
Female |
Right Ear |
0.301 |
0.302 |
|||
Left Ear |
0.303 |
||||||
15 |
Female |
Right Ear |
0.306 |
0.307 |
|||
Left Ear |
0.307 |
||||||
4 |
50% (HM) |
16 |
Female |
Right Ear |
0.295 |
0.295 |
0.299 ± 0.0062 |
Left Ear |
0.294 |
||||||
17 |
Female |
Right Ear |
0.308 |
0.309 |
|||
Left Ear |
0.310 |
||||||
18 |
Female |
Right Ear |
0.293 |
0.294 |
|||
Left Ear |
0.295 |
||||||
19 |
Female |
Right Ear |
0.296 |
0.297 |
|||
Left Ear |
0.298 |
||||||
20 |
Female |
Right Ear |
0.300 |
0.302 |
|||
Left Ear |
0.303 |
Key: mm-Millimeter, LM-Low Mid, HM-High Mid, % - Percent
13.6 EAR THICKNESS MEASUREMENTS ON DAY 6 (Contd.)
Group |
Dose |
Animal Number |
Sex |
Location |
Ear thickness (mm) |
Individual Mean (mm) |
Group Mean ± SD (mm) |
5 |
100% (H) |
21 |
Female |
Right Ear |
0.310 |
0.312 |
0.306 ± 0.0060 |
Left Ear |
0.313 |
||||||
22 |
Female |
Right Ear |
0.307 |
0.308 |
|||
Left Ear |
0.308 |
||||||
23 |
Female |
Right Ear |
0.309 |
0.309 |
|||
Left Ear |
0.308 |
||||||
24 |
Female |
Right Ear |
0.295 |
0.296 |
|||
Left Ear |
0.297 |
||||||
25 |
Female |
Right Ear |
0.307 |
0.308 |
|||
Left Ear |
0.309 |
||||||
6 |
25% (PC) |
26 |
Female |
Right Ear |
0.492 |
0.494 |
0.508 ± 0.0161 |
Left Ear |
0.495 |
||||||
27 |
Female |
Right Ear |
0.509 |
0.510 |
|||
Left Ear |
0.511 |
||||||
28 |
Female |
Right Ear |
0.513 |
0.514 |
|||
Left Ear |
0.515 |
||||||
29 |
Female |
Right Ear |
0.489 |
0.491 |
|||
Left Ear |
0.492 |
||||||
30 |
Female |
Right Ear |
0.529 |
0.530 |
|||
Left Ear |
0.531 |
Key: mm-Millimeter, H-High, PC-Positive Control, % - Percent
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP-compliant study carried out according to OECD guideline 442B, thirty healthy female animals were allocated into six groups, each group consist of five female BALB/c mice. Animals in group 1 (G1) was applied to both ears with vehicle alone (Acetone+Olive oil) in 4:1 ratio and served as Vehicle Control (VC). FAT 40879/B was applied to both ears at the concentrations of 10 % (Low), 25 % (Low Mid), 50 % (High Mid) and 100 % (High) for dose groups G2, G3, G4 and G5, respectively.
In addition, animals in group 6 (G6) (Positive Control) was applied to both ears with reference item Eugenol (25 %). The skin reactions were recorded on day 1-6, ear thickness was measured on Day 1, 3 and 6. All animals were necropsied and examined macroscopically at the end of observation period. The auricular lymph nodes were collected from both ears and analyzed with BrdU ELISA. All the animals appeared normal throughout the acclimatization as well as study observation period. The body weight of the animals was within the normal range of variability commonly recorded for this species, strain and age. No erythema was found in Vehicle Control group and the animals treated with dose concentrations of Low, Low Mid, High Mid and High dose groups from Day 1 to Day 6 whereas, in Positive Control group all the animals showed well defined erythema on both the ears from Day 2 to Day 6. Ear thickness measurement in treated group animals was comparable with Vehicle Control group whereas, ear thickness was slightly increased in Positive Control group from Day 2 to Day 6 when compared with Vehicle Control group. No abnormalities were observed externally and internally in Vehicle Control, Low, Low Mid, High Mid and High dose group animals at necropsy. Ears (bilateral) - reddened, slightly was observed externally and auricular lymph node (bilateral) - enlarged, slightly was observed internally in Positive Control group at terminal sacrifice. BrdU ELISA measurement with Positive Control animal cell suspension of auricular lymph nodes revealed Stimulation Index (SI) value was 4.574. As the SI was greater than 1.6, sensitivity and validity of the test system was confirmed. BrdU ELISA measurement with treated groups (G2 to G5) resulted in 1.068 to 1.212. As the Stimulation Index was less than 1.6, FAT 40879/B is considered not a potential skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the findings in the in vitro skin sensitisation study, the test substance is not considered to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
