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Diss Factsheets

Administrative data

Description of key information

An acute skin irritation study in rabbits has been conducted with the substance Guerbet alcohols, C24-26, branched and linear. The substance showed only slight irritant effects.

An eye irritation study in rabbits is available for Guerbet alcohols, C24-26, branched and linear shows no irritant effects of the substance.

No data on respiratory irritation are available for the substance or any other structurally related Guerbet alcohol.


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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was performed for the notification in other regions where authorities do not accept read-across nor in vitro data.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: laboratory breed, EUROLAP (F-35140 GOSNE)
- Age at study initiation: 9 or 12 weeks old
- Housing: single housing
- Diet (e.g. ad libitum): SAFE - 112, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per kg bw was applied undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, and then 24, 48 and 72 hours aftter patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- coverage: patch (25 mm x 25 mm) non woven swab of 4.layer (MEDISTOCK)
- Type of wrap if used: sugical adhesive tape (50 mm wide hypoallergienic micropore adhesive tape from 3M)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours after patch removal
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 7 or 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 after patch removal
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
A very slight to well defied erythema was noted on the treated area 24 hours after patch removal in all animals which was totally reversible between 7 and 14 days.
Other effects:
On the cutaneous structure, dryness of the skin was noted in one animal on day 3 and in a second animal on day 7. The skin recovered to a normal aspect on day 14.

Table 1: Irritant/corrosive response data for each animal at each observation time point

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

1 h

0/1/1

0/0/0

24 h

 1/2/1

0/0/0

48 h

 1/2/1

0/0/0

72 h

 1/2/1

0/0/0 

Day 7

0/1/0

0/0/0

Day 14

0/0/0

0/0/0

 Average 24h, 48h, 72h  1.33  0

Reversibility*)

   -

 *) Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is slightly irritating to the skin.
Executive summary:

An acute dermal irritation study was conducted on 3 New Zealand rabbits accoidn to OEECD Test Guideline 404. 0.5 ml of the test substace Guerbet alcohols, C24 -26, branched and cyclic were applied to the undamaged skin of the animals under semioccusive conditions for 4 hours. A very slight to well defied erythema was noted on the treated area 24 hours after patch removal in all animals which was totally reversible between 7 and 14 days. Based on the results of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is slightly irritating to the skin.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was performed for the notification in other regions where authorities do not accept read-across nor in vitro data.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: laboratory breed, EUROLAP (F-35140 GOSNE)
- Age at study initiation: 9 or 12 weeks old
- Housing: single housing
- Diet (e.g. ad libitum): SAFE - 112, ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Duration of treatment / exposure:
single administration, in each animal the test article was introduced into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball, afterwards the eyelid was closed for 1 second. The other eye remeined untreated serving as control. Unlimited exposure (not rinsed).
Observation period (in vivo):
1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3 male
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
none

Table 1: Irritant/corrosive response data at each observation time

Score at time point / Reversibility

 

Cornea

Iris

Conjunctivae Redness

Conjunctiva Chemosis

1 h

0 (3)

0 (3)

1 (3)

1 (2) 0 (1)

24 h

0 (3)

0 (3)

1 (2) 0 (1)

0 (3)

48 h 0 (3) 0 (3) 0 (3) 0 (3)
72 h 0 (3) 0 (3) 0 (3) 0 (3)
 Average 24, 48, 72 h 0 0 0.22 0
 Reversibility * n.a. n. a.  c.  c.

 

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible, n.a.= not applicable

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the result of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is not irritating to the eyes.
Executive summary:

An acute eye irritation study was performed in three New Zealand rabboitsa according to OECD tEst Guideline 405. The test item Guerbet alcohols, C24 -26, branched and cyclis was instilled undiluted into the eyes of the rabbits at the dose of 0.1 ml. The ocular reactions observed during the study have been slightl and totally reversible, Based on the result of this study, the substance Guerbet alcohols, C24-26, branched and cyclic is not irritating to the eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The available data are conclusive but not sufficient for classification of Guerbet alcohols, C24-26, branched and linear with regard to irritation/corrosion.