Hexafluoropropene, oxidized, oligomers, reduced, fluorinated

Endpoint summary

Description of key information

An in vivo dermal sensitisation test, conducted according to OECD guideline 406 (Buehler test) is reported.
The study was conducted under GLP, the reliability of the study according to Klimish score is K1.
Basing on the experimental result, according to REGULATION (EC) No 1272/2008, GALDEN LMW does not meet the classification criteria for human health for skin sensitisation.

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:

9 June 1992 to 10 July 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline-conform study conducted under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

(1981)

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The test was performed before the pubblication of the OECD LLNA test (2002) and the adoption of REACH (2006)

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: livestock farming
- Age at study initiation: 1-2 months
- Weight at study initiation: 390-482 g
- Housing: 2 or 3 animals/cage in an air-conditioned room. Wire cages (40.5 x 38.5 x 18)cm with a stainless steel feeder.
- Diet (e.g. ad libitum): Standard GLP diet, available ad libitum.
- Water (e.g. ad libitum): from municipal water main system, filtered and disrtibuted ad libitum
- Acclimation period: Five days. Animals were observed daily to ascertain their fitness for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +- 2
- Humidity (%): 55% +- 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hour cicle (7 a.m.-7 p.m.)

IN-LIFE DATES: From: To: not reported

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5 ml of undiluted test material

Day(s)/duration:

27

Adequacy of induction:

highest technically applicable concentration used

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5 ml of undiluted test material

Day(s)/duration:

Day 28 / 24 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 (10 males for test group + 10 males for control group)
2 animals for the preliminary test

Details on study design:

RANGE FINDING TESTS:
The preliminary test was performed on two animals in order to select the maximum well tolerated concentration for the induction phase and the maximum concentration proved to be not irritating for the challenge exposure.
The test article was assayed undiluted by occlusive patch on two animals. 0.5 ml of the test article was applied onto the skin with a closed patch. Twenty-four hours after administration, the patches were removed and the animals were observed for up to 48 hours for local reaction on the skin area of the patch application.
The test article was well tolerated and not irritant, therefore it was used undiluted in the sensitization test.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: undiluted test material.
- Control group: not treated
- Site: on the shoulder region in an area of about 6x6 cm.
- Frequency of applications: applications were performed on day 0, 7 and 14.
- Duration: 27 days
- Concentrations: 0.5 ml of undiluted test material.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28 from the beginning of the test.
- Exposure period: 24 hours
- Test groups: undiluted test material.
- Control group: undiluted test material.
- Site: on one flank, in an area of about 6x6 cm
- Concentrations: 0.5 ml of undiluted test material.
- Evaluation (hr after challenge): 24 and 48 hours [the skin reactions was read immediately after the patch removal (day 29), and the day after (day 30) ].

OTHER:
The evaluation of skin reaction was according to the following scale:
0,0 normal skin
0,5 very slight erythema
1,0 slight erythema
2,0 moderate-intense erythema, slight edema
3,0 marked erythema and edema

The results were expressed in terms of incidence and severity of response:
INCIDENCE: the number of animals showing responses of 1 or greater at either 24 or 48 hour divided by the number of animals tested.
SEVERITY: the sum of the test grades divided by the number of animals tested.

CLINICAL SIGNS
Animals were checked daily for clinical signs.

BODY WEIGHT
Body weight was recorded pre-trial and weekly thereafter.

Positive control substance(s):

no

Positive control results:

No positive control included in the study

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 ml of undiluted material

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 ml of undiluted material

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.5 ml of undiluted material

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.5 ml of undiluted material

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

other: positive control group was not required by the method.

Group:

positive control

Dose level:

positive control group not required by the method.

Remarks on result:

not measured/tested

The body weight gain of the animals troughout the test was normal.

No animals showed positive reaction at the challenge.

No skin reactivity was observed in the negative control group.

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results, under the experimental conditions applied, GALDEN LMW did not appear to possess sensitizing capacity.

Executive summary:

The potential for the contact sensitization of the test article GALDEN LMW was assessed in the guinea pig using the test described by Buhler, according to OECD guideline No. 406.

A preliminary test was performed in order to select the maximum well tolerated concentration for the induction phase and the maximum concentration proved to be not irritating for the challenge exposure: 0,5 ml of the test article were applied undiluted by occlusive patch on two animals. Twenty-four hours after administration, the patches were removed and the animals were observed for up to 48 hours for local reaction on the skin area of the patch application.

The test article was well tolerated and not irritant, therefore it was used undiluted in the sensitization test.

 

During the 27-day induction phase of the study, 0.5 ml of undiluted GALDEN LMW were applied three times (days 0, 7 and 14) by an occlusive patch to ten guinea pigs. Every exposure had a duration of 6 hours.

At the challenge, on the 28 from the beginning of the test, the previously-exposed ten animals were treated with 0,5 ml of undiluted GALDEN LMW, applied for 24 hours by occlusive patch. In the same way, ten control animals not previously-treated were exposed concurrently.

Skin reaction was read immediately after patch removal, and 24 hour later. Reactions were evaluated according a score system.

Animals were checked daily for clinical signs during the study. Body weight was recorded pre-trial and weekly thereafter.

At the challenge no animals showed positive reaction. No skin reactivity was observed in the negative group. The body weight gain of the animals troughout the test was normal.

On the basis of these results, under the experimental conditions applied, GALDEN LMW did not appear to possess sensitizing capacity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Under the reported in vivo skin sensitisation test, ten guinea pigs were tested according to Buehler test.

A preliminary test was performed in order to select the maximum well tolerated concentration for the induction phase and the maximum concentration proved to be not irritating for the challenge exposure.

During the 27-day induction phase of the study, 0.5 ml of undiluted GALDEN LMW were applied three times (days 0, 7 and 14) by an occlusive patch to ten guinea pigs. Every exposure had a duration of 6 hours.

At the challenge, on the 28th day from the beginning of the test, the previously-exposed ten animals were treated with 0,5 ml of undiluted GALDEN LMW, applied for 24 hours by occlusive patch. In the same way, ten control animals not previously-treated were exposed concurrently.

Skin reaction was read immediately after patch removal, and 24 hour later. Reactions were evaluated according to score system.

No animals showed positive reaction at the challenge. No skin reactivity was observed in the negative group. The body weight gain of the animals troughout the test was normal.

In conclusion GALDEN LMW did not appear to possess sensitizing capacity.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Since no reactions were observed at the challenge in the treated animals, according to REGULATION (EC) No 1272/2008, GALDEN LMW does not meet the classification criteria for human health for skin sentisitisation.