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EC number: 203-784-4
CAS number: 110-62-3
Valid data could be identified for assessment of the skin and eye irritating potential of valeraldehyde.In a primary dermal irritation study, valeraldehyde proved to be a dermal irritant (BASF AG, 1999).In a primary eye irritation study, valeraldehyde demonstrated to be irritating to the eye (BASF AG, 1977).In a sensory irritation experiment, a RD50 of 1120 ppm was determined during inhalation exposure of mice to valeraldehyde (Steinhagen, 1984) indicating the potential of respiratory irritation.
Skin irritation data for valeraldehyde
are reported by BASF (1999) and by Smyth (1969 and 1962).
The BASF study on skin
irritation is a GLP study according to OECD test guideline 404 with a
reliability of 1. It is selected as key study.
The methods and evaluation/scoring
systems used in the studies of Smyth are different from actual
test guidelines with profound deviations and results are not comparable
to data obtained according to recent test guidelines. Furthermore, in
the study from 1962, the test substance (1-pentanal) is indicated as
"mixed isomers" causing doubts on the nature of the test material as
single substance. For both studies, reliability is 3.
BASF AG 1999
In a primary dermal irritation study
according to OECD test guideline 404 (Acute Dermal
Irritation/Corrosion), three young adult male New Zealand White rabbits
were dermally exposed to 0.5 mL of valeraldehyde (purity 98.5%) for 4
hours applied to a 2.5 x 2.5 cm body surface area. Animals then were
observed for 14 days. Irritation was scored according to the grading
system of OECD test guideline 404 (method of Draize).
Erythema was noted starting from 1 h
after removal of the patch (all 3 animals) up to 14 days (1 animal) with
maximum scores of 3. Edema was less pronounced (only 2 animals, shorter
period, maximum score of 2). Mean erythema and edema scores (24. 48, and
72 h, all animals) were 1.78 and 0.44 respectively. In this study, valeraldehyde
was demonstrated to be a dermal irritant (BASF AG, 1999).
Eye irritation data for valeraldehyde
are reported by BASF (1977) and by Smyth (1969 and 1962).
The BASF study on eye
irritation bears some deviations from recent guidelines (only 2 animals
tested, dose applied only 0.05 mL, no grading of eye reaction at 72 h).
Nevertheless, the data are assessed to be sufficiently valid to evaluate
the eye irritation potential of valeraldehyde. Using available date
conforms to the testing and evaluation strategy for eye
irritation/corrosion and helps avoid further testing. This study is
selected as key study.
BASF AG 1977
In an acute eye irritation/corrosion
test, 2 rabbits were exposed to 0.05 mL valeraldehyde each. Irritation
reactions of cornea and conjunctivae developed within 1 hour after
application and persisted up to a maximum of 8 days. At the end of the
observation period (8 days) all irritation effects had subsided.
For rabbit 1, the mean (24 and 48 h,
no reading at 72 h) cornea and conjunctivae score were 0.5 and 1.5
respectively. For rabbit 2, the mean cornea and conjunctivae score were
1.5 and 2 thus exceeded or reaching the EU criteria for classification
(reversible effect on the eye - Category 2) (BASF AG, 1977). Considering
the dose applied and the time course of the development of irritating
effects, valeraldehyde requires classification as irritating
to eyes (Category 2).
In a sensory irritation experiment
conducted following accepted scientific principles, B6C3F1 mice and
Swiss-Webster mice were exposed head only in groups of 4 to graduate
concentrations of valeraldehyde vapor. Respiratory rates were recorded
by means of a body plethysmograph. The average maximum decrease in
respiratory rate for 1 min was computed from the response of each group
of animals. The RD50 value was calculated from the resulting
RD50 values of 1190 ppm and
1121 ppm were determined for B6C3F1 and Swiss-Webster mice,
respectively demonstrating that valeraldehyde is respiratory
irritating (Steinhagen, 1988).
(The endpoint study record for this
study is located in IUCLID Section 7.9.3 - Specific investigations:
Mean erythema score for gradings at
24, 48, and 72 h was 2 and higher for 2 animals out of 3. Thus according
to Directive 67/548/EEC, classification as irritating to skin
is required for valeraldehyde (R38: Irritating to skin).
However, classification criteria of Regulation
(EC) No 1272/2008 are not met. The cut off value of 2.3 for mean
erythema or edema scores from gradings at 24, 48, and 72 h was exceeded
in only one test animal but not in 2 as required. Similarly,
inflammation persisted only in 1 animal until the end of the observation
period (14 d) but not in 2. Thus, no classification
regarding skin irritation under Regulation 1272/2008 is required.
The eye irritation study of BASF
(1977) includes some deviations from test guidelines (amount of test
substance only 0.05 mL, only 2 animals tested, grading only at 24 and 48
h, but not at 72 h).
The scores taken were moderate (mean
of 24 and 48 h gradings 0.5 to 2). The effects observed were totally
reversible within 8 days. This data would indicate classification as
irritating to eyes (Category 2) according to Regulation (EC) No
1272/2008 but no classification according to Directive 67/548/EEC.
As consequence of using the required
amount of test substance in this eye irritation test, more pronounce
effect with higher scores would have been observed. Considering the
scale of effects and the time course reported, it is estimated that
scores would increase but the effects would still be reversible within
the observation period (14 days or 21 days).
In order to avoid further testing and
additional use of test animals, classification will be based on the test
results available under application of the above considerations.
Valeraldehyde will be classified as
irritating to the eye based on both, Directive 67/548/EEC (R 36:
Irritating to eyes) and Regulation (EC) No 1272/2008 (irritating to eyes
- Category 2).
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